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Contact Lens 1210
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1021723Model Diagnostic Contact Lens
Identity
- Trade Name
- Contact Lens 1210 EUDAMEDContact glass Endothel FDA UDI
- Generic Name
- Ophthalmic diagnostic condensing lens FDA UDI
- Device Name
- Contact Lens EUDAMED
- Model / Reference
- Diagnostic Contact Lens EUDAMED1021723 EUDAMEDEndothel FDA UDI
Identifiers
- Catalog Number
- 1021723 FDA UDI
- Primary DI / UDI-DI
- 07640132986495 EUDAMEDFDA UDI
- Basic UDI-DI
- 764013298Contact_Lens5M EUDAMED
- 510(k) Number
- K051103 FDA UDI
- FDA Product Code
- HJK FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic diagnostic condensing lens FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1385 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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
Contact Lens 1210 by Haag-Streit AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764013298Contact_Lens5M | 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 62a5100e-ccfe-4108-b5cc-eed3277c72fd 61 fields · synced Jul 9, 2026
- FDA UDI 542697b0-d1b4-4e35-8257-7352d5f2f1b3 35 fields · synced May 30, 2026