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Rolyan 2oz Therapy Putty – Medium Soft Red)
EUDAMEDClass I (EU MDR)
Ref 081029545Model EXERCISE NON- MEASURING
Identity
- Trade Name
- Rolyan 2oz Therapy Putty – Medium Soft Red) EUDAMED
- Device Name
- HAND TRAINER EUDAMED
- Model / Reference
- EXERCISE NON- MEASURING EUDAMED081029545 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914005675 EUDAMED
- Basic UDI-DI
- 00874530000000000000009XZ EUDAMED
- EMDN Code
- Y0503 HANDS AND FINGERS RE-EDUCATION DEVICES 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
Rolyan 2oz Therapy Putty – Medium Soft Red) by The Hygenic Company, 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 | 00874530000000000000009XZ | 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 c96b6dac-d1a0-4cb8-8721-5c3f13fa189d 61 fields · synced Jul 8, 2026