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T/F Dlx Strap Wedge 6"x20"x22"
EUDAMEDClass I (EU MDR)
Ref 081012152Model EXERCISE THERAPY
Identity
- Trade Name
- T/F DLX STRAP WEDGE 6"X20"X22" EUDAMED
- Device Name
- GROSS MOTOR AND SENSORY STIMULATION DEVICES EUDAMED
- Model / Reference
- EXERCISE THERAPY EUDAMED081012152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914003169 EUDAMED
- Basic UDI-DI
- 08859140000000000000005KU EUDAMED
- EMDN Code
- Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES 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
T/F Dlx Strap Wedge 6"x20"x22" by Performance Health Supply, LLC — 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 | 08859140000000000000005KU | 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 17d876f0-cbd2-4070-be6b-d9fb44fcd910 61 fields · synced Jul 28, 2026