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ROP Pediatric Wire Speculum with Tabs
EUDAMEDClass I (EU MDR)
Ref D10-5388Model D10-5000-9019
Identity
- Trade Name
- ROP Pediatric Wire Speculum with Tabs EUDAMED
- Device Name
- Ophthalmic Speculums EUDAMED
- Model / Reference
- D10-5000-9019 EUDAMEDD10-5388 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G006D1053880F EUDAMED
- Basic UDI-DI
- ++G006OphthalSpeculumU8 EUDAMED
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
ROP Pediatric Wire Speculum with Tabs 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 f1761c98-791d-46fd-b3bb-12f0d0b0d96e 61 fields · synced Jul 16, 2026