Identity
- Device Name
- Opener EUDAMED
- Model / Reference
- 346127 EUDAMED347172 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979333851242 EUDAMED06979333851273 EUDAMED
- Basic UDI-DI
- 697933385opener001KQ EUDAMED
- EMDN Code
- Y242199 DEVICES FOR REACHING AND GRASPING OBJECTS - 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
Opener 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 | 697933385opener001KQ | 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 93a8f36d-0d9d-4bcc-a4ae-061e3e2ead8e 61 fields · synced Jul 28, 2026
- EUDAMED d5ea3ae7-fb7b-40e0-95bc-13cb57baa3a9 61 fields · synced May 17, 2026