Identity
- Trade Name
- Reset Button EUDAMED
- Device Name
- Hospital Monitoring System EUDAMED
- Model / Reference
- WC-DARE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978354070076 EUDAMED
- Basic UDI-DI
- 6978354070007DB EUDAMED
- EMDN Code
- Y215199 ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia 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
Reset Button by Contin Technology Limited — 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 | 6978354070007DB | Class I | Active |
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Manufacturer
- Manufacturer
- Contin Technology Limited
- EUDAMED SRN
- HK-MF-000046788
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED b02e519a-10da-4de1-84eb-859c71ea48f0 61 fields · synced Jun 18, 2026