Identity
- Device Name
- Gel Ball EUDAMED
- Model / Reference
- 340395 EUDAMED340398 EUDAMED340397 EUDAMED340396 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979333851440 EUDAMED06979333851464 EUDAMED06979333851419 EUDAMED06979333851426 EUDAMED
- Basic UDI-DI
- 697933385ball0032Y EUDAMED
- EMDN Code
- Y0503 HANDS AND FINGERS RE-EDUCATION DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Gel Ball by Hangzhou Royal Craft Industrial Co., LTD. — 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 | 697933385ball0032Y | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Royal Craft Industrial Co., LTD.
- EUDAMED SRN
- CN-MF-000050897
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (4)
- EUDAMED fa29fc79-0b58-47e9-aa19-e329832988ac 61 fields · synced Jul 22, 2026
- EUDAMED 254e3728-112e-438d-80f0-7c9d0f752d76 61 fields · synced May 18, 2026
- EUDAMED 07676dfe-1c32-4a32-ba4a-7a413313d755 61 fields · synced May 18, 2026
- EUDAMED b9f176df-06b1-4932-be07-05432a1a69e9 61 fields · synced May 18, 2026