Identity
- Trade Name
- Contact Lens CGRL EUDAMEDContact glass CGRL FDA UDI
- Generic Name
- Ophthalmic diagnostic condensing lens FDA UDI
- Device Name
- Laser Contact Lens EUDAMED
- Model / Reference
- 1400442 EUDAMEDCGRL FDA UDI
Identifiers
- Catalog Number
- 1400442 FDA UDI
- Primary DI / UDI-DI
- 07640132986471 EUDAMEDFDA UDI
- Basic UDI-DI
- 764013298L_Contact_LensCH EUDAMED
- Direct Marketing DI
- 07640132986471 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 CGRL 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 | 764013298L_Contact_LensCH | 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 8231b402-a05a-4637-a27f-a7f2fac2e02c 61 fields · synced Sep 18, 2026
- FDA UDI 4b34e594-2105-4115-a327-3fb7136288d8 35 fields · synced May 30, 2026