Identity
- Trade Name
- Ophthalmic/Otologic Diagnostic Set EUDAMED
- Device Name
- Ophthalmic/Otologic Diagnostic Set EUDAMED
- Model / Reference
- 20.000.125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904507276911 EUDAMED
- Basic UDI-DI
- 590450727TP28F9 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 AUG MEDICAL Spółka z ograniczoną odpowiedzialnością — 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 | 590450727TP28F9 | Class I | Active |
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Manufacturer
- Manufacturer
- AUG MEDICAL Spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000019086
Sources (1)
- EUDAMED 7375bbe8-25df-4da2-aa67-1a66024b04d1 61 fields · synced Oct 7, 2026