Identity
- Trade Name
- SPATULA, OPHTHALMIC EUDAMED
- Device Name
- PGM00006 EUDAMED
- Model / Reference
- ES-0921 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251047927591 EUDAMED
- Basic UDI-DI
- 42510479PGM000069K EUDAMED
- Direct Marketing DI
- 04251047927591 EUDAMED
- EMDN Code
- L1706 OPHTHALMOLOGY SPATULAS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Ocular hook/spatula/manipulator, reusable
Spatula, Ophthalmic by a1 medical GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ocular hook/spatula/manipulator, reusable.
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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 | 42510479PGM000069K | Class I | Active |
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Manufacturer
- Manufacturer
- a1 medical GmbH
- EUDAMED SRN
- DE-MF-000006489
Sources (1)
- EUDAMED 585a2794-efad-4736-95c9-11df462bd689 61 fields · synced Jun 18, 2026