Identity
- Trade Name
- Green System MRI Handle / Standard EUDAMED
- Device Name
- MRI Laryngoscope, reusable EUDAMED
- Model / Reference
- 5010010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051977001922 EUDAMED
- Basic UDI-DI
- 5051977LAR-MRIRUBLJA EUDAMED
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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: Laryngoscope blade, reusable
Green System MRI Handle / Standard by Penlon Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5051977LAR-MRIRUBLJA | Class I | Active |
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Manufacturer
- Manufacturer
- Penlon Limited
- EUDAMED SRN
- GB-MF-000025115
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED ecf92144-3cd1-40a6-bd97-b635c2700f8b 61 fields · synced Jun 20, 2026