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Rolyan Post-Op Shoe, Men, L, 1/EA
EUDAMEDClass I (EU MDR)
Ref 081193523Model Orthopedics
Identity
- Trade Name
- Rolyan Post-Op Shoe, Men, L, 1/EA EUDAMED
- Device Name
- Lower Extremity EUDAMED
- Model / Reference
- Orthopedics EUDAMED081193523 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914020128 EUDAMED
- Basic UDI-DI
- 08859140000000000000008L2 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES 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
Category: Ankle/foot orthosis
Rolyan Post-Op Shoe, Men, L, 1/EA by Performance Health Supply, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 08859140000000000000008L2 | Class I | Active |
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Manufacturer
- Manufacturer
- Performance Health Supply, LLC
- EUDAMED SRN
- US-MF-000003318
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 501b51fd-3be7-4771-b756-fc151344ad68 61 fields · synced Jul 28, 2026