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Contact Lens 907 without ring
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1021994Model Diagnostic Contact Lens
Identity
- Trade Name
- Contact Lens 907 without ring EUDAMEDContact glass 907 FDA UDI
- Generic Name
- Ophthalmic diagnostic condensing lens FDA UDI
- Device Name
- Contact Lens EUDAMED
- Model / Reference
- Diagnostic Contact Lens EUDAMED1021994 EUDAMED907 without ring FDA UDI
Identifiers
- Catalog Number
- 1021994 FDA UDI
- Primary DI / UDI-DI
- 07640132986426 EUDAMEDFDA UDI
- Basic UDI-DI
- 764013298Contact_Lens5M EUDAMED
- Direct Marketing DI
- 07640132986426 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 907 without ring 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 e601a8c4-2b9b-4baf-95ce-ed2a96c8d6b4 61 fields · synced Jun 19, 2026
- FDA UDI 3ed72bc8-c334-4097-b9ce-931fc6ec5c1b 35 fields · synced May 30, 2026