Identity
- Trade Name
- Encore EUDAMED
- Model / Reference
- Encore Liners and Sleeves EUDAMED18U-6/6-LL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840259501923 EUDAMED
- Basic UDI-DI
- 08402595E21PZ EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Encore by Thermo-Ply, 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 | 08402595E21PZ | Class I | Active |
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Manufacturer
- Manufacturer
- Thermo-Ply, Inc.
- EUDAMED SRN
- US-MF-000038601
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED b8f4b0c6-704b-4d04-90a3-eeb55b2c677a 61 fields · synced Jun 20, 2026