Identity
- Device Name
- AFO Posterior Spring EUDAMED
- Model / Reference
- TN200-KIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00645517899398 EUDAMED
- Basic UDI-DI
- 00645517AFOSpringWD EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN ANKLE-FOOT ORTHOSES 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
AFO Posterior Spring by Trulife Inc. — 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 | 00645517AFOSpringWD | Class I | Active |
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Manufacturer
- Manufacturer
- Trulife Inc.
- EUDAMED SRN
- US-MF-000009657
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 7c8d7e7a-713f-40cb-810a-cf25c89503fb 61 fields · synced Jul 14, 2026