Identity
- Trade Name
- Baseline EUDAMED
- Device Name
- REFERENCE PRODUCTS EUDAMED
- Model / Reference
- 120240 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00714905013507 EUDAMED
- Basic UDI-DI
- 714905TF09RP45 EUDAMED
- EMDN Code
- Y99 DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Baseline 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 | 714905TF09RP45 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fabrication Enterprises
- EUDAMED SRN
- US-MF-000014521
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (1)
- EUDAMED 6e73783e-565d-4f38-b69b-07750345826f 61 fields · synced Jun 18, 2026