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Temporal Approaach Wire Speclum, Open Wire.
EUDAMEDClass I (EU MDR)
Ref D10-5015Model D10-5000-9019
Identity
- Trade Name
- TEMPORAL APPROAACH WIRE SPECLUM, OPEN WIRE. EUDAMED
- Device Name
- Ophthalmic Speculums EUDAMED
- Model / Reference
- D10-5000-9019 EUDAMEDD10-5015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G006D10501502 EUDAMED
- Basic UDI-DI
- ++G006OphthalSpeculumU8 EUDAMED
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Temporal Approaach Wire Speclum, Open Wire. by Daud Jee Mfg. Co — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G006OphthalSpeculumU8 | Class I | Active |
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Manufacturer
- Manufacturer
- Daud Jee Mfg. Co
- EUDAMED SRN
- PK-MF-000009615
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d9b95586-6596-436e-9012-d9af657ef841 61 fields · synced Aug 2, 2026