Identity
- Trade Name
- sofie EUDAMED
- Device Name
- Sofie EUDAMED
- Model / Reference
- 17 01 100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251040200318 EUDAMED
- Basic UDI-DI
- 4251040200004000170XXXXA6 EUDAMED
- Direct Marketing DI
- 04251040200318 EUDAMED
- EMDN Code
- Y180939 MODULAR POSTURE SYSTEMS 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
sofie by Schuchmann GmbH & Co. KG — 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 | 4251040200004000170XXXXA6 | Class I | Active |
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Manufacturer
- Manufacturer
- Schuchmann GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000013435
Sources (1)
- EUDAMED eb648c99-ac4a-4e08-b139-3f054fdbee8d 61 fields · synced Jun 18, 2026