Identity
- Device Name
- Massage Ball EUDAMED
- Model / Reference
- 344725 EUDAMED340744 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979333851365 EUDAMED06979333851396 EUDAMED
- Basic UDI-DI
- 697933385ball0012U EUDAMED
- EMDN Code
- Y0599 LEARNING AND TRAINING DEVICES - OTHER 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
Massage 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 | 697933385ball0012U | 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 (2)
- EUDAMED 16989040-6e8e-40b7-8df7-b5900cf2def6 61 fields · synced Jul 15, 2026
- EUDAMED 2c4738df-e0bb-40f0-9b93-a13013e9dcfa 61 fields · synced May 19, 2026