Data / Medical devices / United Kingdom / Meditech Systems Limited
Meditech Systems Limited: FDA-registered device maker in Shaftesbury Dorset, United Kingdom, 1 510(k) clearance
Meditech Systems Limited is registered with the FDA (registration 3010439239) in Shaftesbury Dorset, United Kingdom. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010439239
- Address
- shrublands Estate Shearstock, Shaftesbury Dorset, United Kingdom, SP79PT
- Owner or operator
- Meditech Systems Limited (10048739)
- Roles
- Contract sterilizer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- February 20, 2015
- Registered through
- 2026
- Brand names listed
- MEDIZIP, Meditech, Meditech Anesthesia Mask, Meditech Breathing Bag 0.5 Litre, Meditech Breathing Bag 1 Litre, Meditech Breathing Bag 2 Litre, Meditech Breathing Bag 3 Litre, VAD Valsalva Assist Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Reservoir | BTC | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Tubing And Tubing/Filter Fits | NVT | 1 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | 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 |
|---|---|---|---|---|---|---|
| March 16, 2020 | K192713 | Altera Filter and HME/Filter | CAH | Substantially Equivalent | Meditera Tibbi Malzeme San VE Tic AS | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Nasal, Oxygen
- All makers of Tape And Bandage, Adhesive
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Tubing And Tubing/Filter Fits
- All makers of Connector, Airway (Extension)
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Updated March 16, 2020. 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.