Identity
- Trade Name
- ProSeal SIL Liner EUDAMED
- Device Name
- ProSeal SIL Liner EUDAMED
- Model / Reference
- 6Y81 EUDAMED6Y81=340 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032767157785 EUDAMED
- Basic UDI-DI
- 403276700000000006Y81YX EUDAMED
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) 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
Category: Mechatronic external knee prosthesis
ProSeal SIL Liner by Ottobock SE & Co. KGaA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 403276700000000006Y81YX | Class I | Active |
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Manufacturer
- Manufacturer
- Ottobock SE & Co. KGaA
- EUDAMED SRN
- DE-MF-000010487
Sources (1)
- EUDAMED fce8e152-fc6c-4987-9a63-b91d3e4d240d 61 fields · synced Sep 17, 2026