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Ophthalmic/Otologic Diagnostic Set
EUDAMEDClass I (EU MDR)
Ref FMO-001-7700-95.2
Identity
- Trade Name
- Ophthalmic/Otologic Diagnostic Set EUDAMED
- Device Name
- Ophthalmic/Otologic Diagnostic Set EUDAMED
- Model / Reference
- FMO-001-7700-95.2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003751265 EUDAMED
- Basic UDI-DI
- 8964003248DS046P EUDAMED
- EMDN Code
- L1699,Z12149099 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Ophthalmic/Otologic Diagnostic Set by SG Manufacturers — 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 | 8964003248DS046P | Class I | Active |
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Manufacturer
- Manufacturer
- SG Manufacturers
- EUDAMED SRN
- PK-MF-000007106
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 1c338271-e9c0-4c0e-a6f7-3bc965b67d59 61 fields · synced Jul 22, 2026