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Int’l THERABAND® Pro Series SCP™ Exercise Ball - 55 cm Red (display packaging)
EUDAMEDClass I (EU MDR)
Ref 12041Model EXERCISE NON- MEASURING
Identity
- Trade Name
- Int’l THERABAND® Pro Series SCP™ Exercise Ball - 55 cm Red (display packaging) EUDAMED
- Device Name
- EXERCISE BALL EUDAMED
- Model / Reference
- EXERCISE NON- MEASURING EUDAMED12041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453120417 EUDAMED
- Basic UDI-DI
- 00874530000000000000006XT EUDAMED
- EMDN Code
- Z120603 PASSIVE REHABILITATIVE GYMNASTICS EQUIPMENT 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
Int’l THERABAND® Pro Series SCP™ Exercise Ball - 55 cm Red (display packaging) by The Hygenic Company, LLC — Class I — MDR — listed in EUDAMED
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 | 00874530000000000000006XT | Class I | Active |
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Manufacturer
- Manufacturer
- The Hygenic Company, LLC
- EUDAMED SRN
- US-MF-000003317
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED d71fb916-9d51-4061-8829-e1a33282efd7 61 fields · synced Jul 8, 2026