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Easy Skin Cover w/ Hair
EUDAMEDClass I (EU MDR)
Ref TSKH-11-LRef TSK-11-LRef TSK-9-LRef TSK-5-SRef TSKH-13-LRef TSKH-3-LRef TSK-11-SRef TSK-9-SRef TSK-13-SRef TSK-12-LRef TSKH-12-SRef TSKH-7-LRef TSKH-5-S
Identity
- Trade Name
- Easy Skin Cover w/ Hair EUDAMEDEasy Skin Cover EUDAMED
- Device Name
- EASYSKIN EUDAMED
- Model / Reference
- TSKH-11-L EUDAMEDTSK-11-L EUDAMEDTSK-9-L EUDAMEDTSK-5-S EUDAMEDTSKH-13-L EUDAMEDTSKH-3-L EUDAMEDTSK-11-S EUDAMEDTSK-9-S EUDAMEDTSK-13-S EUDAMEDTSK-12-L EUDAMEDTSKH-12-S EUDAMEDTSKH-7-L EUDAMEDTSKH-5-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00713980003649 EUDAMED00713980003472 EUDAMED00713980003458 EUDAMED00713980003403 EUDAMED00713980003663 EUDAMED00713980003564 EUDAMED00713980003465 EUDAMED00713980003441 EUDAMED00713980003540 EUDAMED00713980003496 EUDAMED00713980005766 EUDAMED00713980003601 EUDAMED00713980003571 EUDAMED
- Basic UDI-DI
- 07139801000301078 EUDAMED
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) 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
Easy Skin Cover w/ Hair 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 | 07139801000301078 | Class I | Active |
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Manufacturer
- Manufacturer
- Alps South, LLC
- EUDAMED SRN
- US-MF-000001260
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (13)
- EUDAMED a0ea694a-f75f-43a5-b0fa-26926a3af7ce 61 fields · synced Aug 4, 2026
- EUDAMED cc50c80c-eb06-4309-8be1-374fd0798626 61 fields · synced May 16, 2026
- EUDAMED 37d02f3e-2305-43c6-a811-a8c4e100979d 61 fields · synced May 16, 2026
- EUDAMED d419bdc7-d241-48a6-887a-2b17d47b67cc 61 fields · synced May 17, 2026
- EUDAMED 3fbfe716-ac9b-47af-a073-f5dff41bf32e 61 fields · synced May 17, 2026
- EUDAMED 9cba26fc-180f-4170-8e27-12ccb2dfe558 61 fields · synced May 17, 2026
- EUDAMED 8545b011-68d5-4c10-a06b-886eb8d7c0e2 61 fields · synced May 17, 2026
- EUDAMED 550febd8-dc68-4e1a-9ea0-e92aebceb04a 61 fields · synced May 17, 2026
- EUDAMED b6e8b20d-4d0a-4f37-935b-6863266520fb 61 fields · synced May 17, 2026
- EUDAMED 8de0a7ee-a863-4785-8792-13cd32efb799 61 fields · synced May 18, 2026
- EUDAMED 13f9ac74-c1e8-4a2f-8446-1f18acc110ee 61 fields · synced May 18, 2026
- EUDAMED 1c230407-a99b-482b-bd48-d616f45d3887 61 fields · synced May 18, 2026
- EUDAMED 868c49db-eaa7-4264-bc48-a0fdc050750a 61 fields · synced May 18, 2026