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Compact Sakl Bonded Pyr Ankle
EUDAMEDClass I (EU MDR)
Ref P019267Model Compact SAKL
Identity
- Trade Name
- COMPACT SAKL BONDED PYR ANKLE EUDAMED
- Device Name
- Compact SAKL EUDAMED
- Model / Reference
- Compact SAKL EUDAMEDP019267 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05050649091162 EUDAMED
- Basic UDI-DI
- 5050649COMPACTSAKLM3 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
Compact Sakl Bonded Pyr Ankle by Blatchford Products Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Mechatronic external knee prosthesis.
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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 | 5050649COMPACTSAKLM3 | Class I | Active |
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Manufacturer
- Manufacturer
- Blatchford Products Limited
- EUDAMED SRN
- UK-MF-000048777
- Authorised Representative
- Blatchford Europe GmbH DE-AR-000006292
Sources (1)
- EUDAMED b7cffbf9-10e5-4fe8-934a-f2933d9d05fc 61 fields · synced Jul 11, 2026