Data / Medical devices / United Kingdom / Haag-Streit Uk Ltd.
Haag-Streit Uk Ltd.: FDA-registered device maker in Bishop's Stortford Hertfordshire, United Kingdom, 1 510(k) clearance
Haag-Streit Uk Ltd. is registered with the FDA (registration 3004950803) in Bishop's Stortford Hertfordshire, United Kingdom. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 18, 1996. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004950803
- Address
- Unit C, Woodside, Woodside Industrial Estate Dunmow Road, Bishop's Stortford Hertfordshire, United Kingdom, CM23 5RG
- Owner or operator
- HAAG-STREIT HOLDING (8031066)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- September 13, 1994
- Registered through
- 2027
- Brand names listed
- 123 STEREOGRAMS PER PKT 0F 100, BAILEY-LOVIE WORD READING CHRT, CAMBRIDGE CROWDING CARDS,COMP, CAMBRIDGE L/C SENSITIVITY GRTG, CAT STEREOGRAMES, CAT STEROGRAMS, CLIP-ON PRISMS, FRISBY STEREOTEST and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chart, Visual Acuity | HOX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Measuring, Stereopsis | HLC | 1 | Exporter to the US | accessdata.fda.gov |
| Reader, Prism, Ophthalmic | HJX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Strip, Schirmer | KYD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Target, Fusion And Stereoscopic | HLP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 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 |
|---|---|---|---|---|---|---|
| July 18, 1996 | K961512 | PERKINS HAND-HELD APPLANATION TONOMETER | HKY | Substantially Equivalent | Clement Clarke, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Ent Manual Surgical
- All makers of Target, Fusion And Stereoscopic
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Strip, Schirmer
- All makers of Chart, Visual Acuity
- All makers of Instrument, Measuring, Stereopsis
Updated July 18, 1996. 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.