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Afo Splints
EUDAMEDClass I (EU MDR)
Ref 81285709Model OrthopedicsRef 81285659Ref 81285584Ref 81277474Ref 81269091
Identity
- Trade Name
- AFO SPLINTS EUDAMED
- Device Name
- Lower Extremity EUDAMED
- Model / Reference
- Orthopedics EUDAMED81285709 EUDAMED81285659 EUDAMED81285584 EUDAMED81277474 EUDAMED81269091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914034583 EUDAMED00885914034538 EUDAMED00885914034507 EUDAMED00885914031001 EUDAMED00885914028490 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
Afo Splints 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 (5)
- EUDAMED 990b3fb1-17ac-4622-84f1-bdcb5da3c67a 61 fields · synced Aug 3, 2026
- EUDAMED 500c5154-5bef-48c1-9a27-33a92e0d43d9 61 fields · synced May 17, 2026
- EUDAMED c47fa43e-2ee1-4a46-b815-be186deb8508 61 fields · synced May 18, 2026
- EUDAMED 5c00da58-9642-43c7-80a3-fcc8bc404cc4 61 fields · synced May 18, 2026
- EUDAMED 170ef48a-45d7-4710-8cf0-0a39261f8933 61 fields · synced May 18, 2026