← Back to catalogue
Rolyan Post-Op Shoe, Men, M, 1/EA
EUDAMEDClass I (EU MDR)
Ref 081193515Model Orthopedics
Identity
- Trade Name
- Rolyan Post-Op Shoe, Men, M, 1/EA EUDAMED
- Device Name
- Lower Extremity EUDAMED
- Model / Reference
- Orthopedics EUDAMED081193515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914020111 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, M, 1/EA by Performance Health Supply, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ankle/foot orthosis.
- Strp Only, Long, SA Wide Fl 12.5 E Stop — Becker Orthopedic Appliance Company · Class I
- Strp, SFL, 8.25in C Stop , AJT, SA, B — Becker Orthopedic Appliance Company · Class I
- Strp, Spl, WF Cal Pl, AJT, SA B, Free Mot LM/RL — Becker Orthopedic Appliance Company · Class I
- ALIMED ANKLE BRACE ALL AIR TUBE — AliMed, LLC · Class I
- Ankle support with 2 straps - Neoprene - onesize — ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. · Class I
- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Performance Health Supply, LLC
- EUDAMED SRN
- US-MF-000003318
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED c9f6551c-30f7-4fb8-9681-2047c0c0af40 61 fields · synced Jul 25, 2026