Identity
- Trade Name
- Light sources EUDAMED
- Device Name
- Light sources EUDAMED
- Model / Reference
- HS5612 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978670910261 EUDAMED
- Basic UDI-DI
- 697867091HS5619QQ EUDAMED
- EMDN Code
- Z11030201 CONVENTIONAL MAMMOGRAPHY SYSTEMS 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
Light sources by Danyang New Hope Medical Equipment 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 | 697867091HS5619QQ | Class I | Active |
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Manufacturer
- Manufacturer
- Danyang New Hope Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000027193
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 27ed22d9-0637-45dd-bb7a-bf7bbabfce81 61 fields · synced Jun 18, 2026