Identity
- Trade Name
- Ophthalmoscopes EUDAMED
- Device Name
- Ophthalmoscopes EUDAMED
- Model / Reference
- OPHS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003662547 EUDAMED
- Basic UDI-DI
- 8964003662OPHSDJ EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES 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
Ophthalmoscopes by CENTRAL SURGICAL Co. (PVT) LTD. — 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 | 8964003662OPHSDJ | Class I | Active |
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Manufacturer
- Manufacturer
- CENTRAL SURGICAL Co. (PVT) LTD.
- EUDAMED SRN
- PK-MF-000035590
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 226797ce-2357-4a94-a44f-b08511946f81 61 fields · synced Jul 15, 2026