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Tenax Black DT 38-6 w/Reinforcement Strip
EUDAMEDClass I (EU MDR)
Ref CLBLDT38-6
Identity
- Trade Name
- Tenax Black DT 38-6 w/Reinforcement Strip EUDAMED
- Device Name
- TENAX & PULSE LINER EUDAMED
- Model / Reference
- CLBLDT38-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00713980038849 EUDAMED
- Basic UDI-DI
- 07139801000102475 EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Tenax Black DT 38-6 w/Reinforcement Strip by Alps South, LLC — 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 | 07139801000102475 | Class I | Active |
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Manufacturer
- Manufacturer
- Alps South, LLC
- EUDAMED SRN
- US-MF-000001260
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 72966641-9ccf-402e-b9b0-d785e8394c93 61 fields · synced Jul 8, 2026