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Pavlik Harness White With Bootees Xs
EUDAMEDClass I (EU MDR)
Ref CK-T871601Model Orthopaedic Support Braces
by Trulife
Identity
- Trade Name
- PAVLIK HARNESS WHITE WITH BOOTEES XS EUDAMED
- Device Name
- Orthopaedic Support Braces EUDAMED
- Model / Reference
- Orthopaedic Support Braces EUDAMEDCK-T871601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056311110421 EUDAMED
- Basic UDI-DI
- 00643293OrthoX9 EUDAMED
- EMDN Code
- Y061215 HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Pavlik Harness White With Bootees Xs by Trulife — 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 | 00643293OrthoX9 | Class I | Active |
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Manufacturer
- Manufacturer
- Trulife
- EUDAMED SRN
- IE-MF-000003108
Sources (1)
- EUDAMED fed0f337-dccb-4a01-a420-c6c98db96f0a 61 fields · synced Jun 19, 2026