Identity
- Trade Name
- Skillbuilders EUDAMED
- Device Name
- POSITIONING PRODUCTS EUDAMED
- Model / Reference
- 301070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00714905022837 EUDAMED
- Basic UDI-DI
- 714905TF05FP2D EUDAMED
- EMDN Code
- Y180999 CHAIRS / POSTURE SYSTEMS / SEAT POSITIONING AIDS - OTHER 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
Skillbuilders by Fabrication Enterprises — 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 | 714905TF05FP2D | Class I | Active |
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Manufacturer
- Manufacturer
- Fabrication Enterprises
- EUDAMED SRN
- US-MF-000014521
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (1)
- EUDAMED c2c10602-3f8d-4f84-ab5c-dac6db4a9763 61 fields · synced Jul 9, 2026