Identity
- Trade Name
- Measuring Prism EUDAMEDTonometer Measuring Prism FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Measuring Prism EUDAMED
- Model / Reference
- 1000855 EUDAMEDn/a FDA UDI
Identifiers
- Catalog Number
- 1000855 FDA UDI
- Primary DI / UDI-DI
- 07640132981452 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640132981452 EUDAMED
- FDA Product Code
- HKY FDA UDI
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
- GMDN Term
- Ophthalmic tonometer, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Measuring Prism by Haag-Streit AG — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640132981452 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Haag-Streit AG
- EUDAMED SRN
- CH-MF-000020981
- Authorised Representative
- Haag-Streit Deutschland GmbH DE-AR-000025462
Sources (2)
- EUDAMED 4297957b-34b9-4deb-acb2-2c0fc05777b6 61 fields · synced Jun 18, 2026
- FDA UDI c892dc4d-2108-4443-8dab-09b37cde40d6 34 fields · synced May 30, 2026