Identity
- Device Name
- Spatula, Spatel EUDAMED
- Model / Reference
- 250-540 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049113062433 EUDAMED
- Basic UDI-DI
- 404911314601R002001001ZK EUDAMED
- Direct Marketing DI
- 04049113062433 EUDAMED
- EMDN Code
- L0807 THORACIC SURGERY 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
Spatula, Spatel by ELCON Medical Instruments GmbH — 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 | 404911314601R002001001ZK | Class I | Active |
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Manufacturer
- Manufacturer
- ELCON Medical Instruments GmbH
- EUDAMED SRN
- DE-MF-000005908
Sources (1)
- EUDAMED 686b4926-a5d8-4f1f-b1e5-91b15340c1b7 61 fields · synced Jul 8, 2026