Data / Medical devices / United Kingdom / Mast Group Ltd.
Mast Group Ltd.: FDA-registered device maker in BOOTLE, MERSEYSIDE Liverpool, United Kingdom, 60 510(k) clearances
Mast Group Ltd. is registered with the FDA (registration 8020667) in BOOTLE, MERSEYSIDE Liverpool, United Kingdom. It lists 10 device types. The FDA files 60 510(k) clearances under its listings, the newest dated August 20, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020667
- FEI number
- 4247
- Address
- Mast House, Derby RD., BOOTLE, MERSEYSIDE Liverpool, United Kingdom, L20 1EA
- Owner or operator
- MAST GROUP LTD. (8020667)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 6, 1999
- Registered through
- 2026
- Brand names listed
- CoaguStaph, Eravacycline, Hardy Discs, Hardy Disks, HardyDisk AST Gepotidacin, HardyDisk Aztreonam/Avibactam, HardyDisk AST Cefiderocol, HardyDisk AST Tebipenem 10µg and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antisera, All Groups, Salmonella Spp. | GRM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Antisera, All Types, Escherichia Coli | GNA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Antisera, All Types, H. Influenza | GRP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Antisera, All Types, Shigella Spp. | GNB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Antiserum, Vibrio Cholerae, All Varieties | GSQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Discs, Strips And Reagents, Microorganism Differentiation | JTO | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Screening, Urine | JXA | 1 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulase, Human, Horse And Rabbit | JTL | 1 | Manufacturer | accessdata.fda.gov |
| Susceptibility Test Discs, Antimicrobial | JTN | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | MYI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 20, 2026 | K262113 | HardyDisk AST Tebipenem 10µg (TBP10) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| May 11, 2026 | K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| November 20, 2025 | K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| May 15, 2025 | K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| July 6, 2023 | K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| June 1, 2023 | K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| September 19, 2019 | K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| July 31, 2019 | K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| September 26, 2018 | K182357 | HardyDisk AST Eravacycline 20µg (ERV20) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| July 10, 2018 | K181700 | HardyDisk AST Plazomicin 30ug (PLZ30) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| October 3, 2017 | K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| August 1, 2017 | K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5) | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| November 24, 2015 | K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| November 24, 2015 | K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| December 17, 2010 | K103538 | HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| January 29, 2008 | K080019 | HARDYDISK AST DORIPENEM 10 UG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| October 18, 2006 | K062864 | MASTALEX -MRSA, MODEL RST501 | MYI | Substantially Equivalent | Mast Group , Ltd. | accessdata.fda.gov |
| August 23, 2006 | K062245 | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| June 13, 2001 | K011384 | HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 26, 2001 | K011086 | HARDYDISK BACITRACIN, 10MCG, MODEL Z927 | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| January 25, 2001 | K003690 | HARDYDISK SULFISOXAZOLE | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| January 19, 2001 | K003554 | HARDYDISK TRIMETHOPRIM 5MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| January 17, 2001 | K003556 | HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| November 2, 2000 | K002662 | HARDYDISK CLINDAMYCIN, 2MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| October 26, 2000 | K002664 | HARDYDISK LEVOFLOXACIN, 5MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| October 26, 2000 | K002661 | HARDYDISK CEFOTETAN, 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| October 25, 2000 | K002656 | HARDYDISK CEFUROXIME, 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| July 27, 2000 | K001728 | HARDY DISK CLARITHROMYCIN, 15MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 13, 2000 | K000526 | HARDYDISK, CEPHALOTHIN 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 7, 2000 | K000525 | HARDYDISK OFLOXACIN 5MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 7, 2000 | K000524 | HARDYDISK, CEFOTAXIME 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 7, 2000 | K000509 | HARDYDISK, VANCOMYCIN 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 7, 2000 | K000440 | HARDYDISK CEFTRIAXONE 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 7, 2000 | K000272 | HARDYDISK, NITROFURANTOIN | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 7, 2000 | K000271 | HARDYDISK, SULFA/TRIMETH | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 7, 2000 | K000268 | HARDYDISK, AMPICILLIN, 10MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| April 7, 2000 | K000261 | HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| March 31, 2000 | K000305 | HARDYDISK, CEFOXITIN, 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| March 29, 2000 | K000304 | HARDYDISK, TETRACYCLINE 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| March 24, 2000 | K000302 | HARDY DISK, PENICILLIN, 10 UNITS | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| March 21, 2000 | K000259 | HARDYDISK, CEFTAZIDIME, 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| March 21, 2000 | K000258 | HARDYDISK, CIPROFLOXACIN, 5MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| March 21, 2000 | K000203 | HARDYDISK, KANAMYCIN, 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| March 2, 2000 | K000181 | HARDYDISK, CARBENICILLIN, 100MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 29, 2000 | K000201 | HARDYDISK, STREPTOMYCIN 10MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 29, 2000 | K000182 | HARDYDISK TOBRAMYCIN, 10MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 29, 2000 | K000130 | HARDYDISK, NALIDIXIC ACID, 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 28, 2000 | K000183 | HARDYDISK, PIPERACILLIN, 100MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 18, 2000 | K000128 | HARDYDISK, CEFAZOLIN, 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 17, 2000 | K994134 | HARDYDISK OXACILLIN, 1MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 16, 2000 | K994150 | HARDYDISK NORFLOXACIN, 10MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 16, 2000 | K994135 | HARDYDISK ERYTHROMYCIN, 15MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 11, 2000 | K994091 | HARDYDISK GENTAMICIN, 10MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 11, 2000 | K994089 | HARDYDISK CHLORAMPHENICOL, 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| February 1, 2000 | K994046 | HARDYDISK CEFACLOR 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| January 18, 2000 | K994132 | HARDYDISK IMIPENEM, 10MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| January 14, 2000 | K994067 | HARDY DISK AMPICILLIN/SULBACTAM | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| January 10, 2000 | K994051 | HARDYDISK DOXYCYCLINE, 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| December 27, 1999 | K993993 | HARDYDISK AMIKACIN 30MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
| December 21, 1999 | K993994 | HARDYDISK AZITHROMYCIN 15MCG | JTN | Substantially Equivalent | Hardy Diagnostics | accessdata.fda.gov |
Compare with other makers
- All makers of Susceptibility Test Discs, Antimicrobial
- All makers of Plasma, Coagulase, Human, Horse And Rabbit
- All makers of Antiserum, Vibrio Cholerae, All Varieties
- All makers of Antisera, All Types, H. Influenza
- All makers of Antisera, All Groups, Salmonella Spp.
- All makers of System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Updated August 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.