Identity
- Trade Name
- Surgical Lights EUDAMED
- Device Name
- Surgical Lights EUDAMED
- Model / Reference
- OL9550 EUDAMED118000002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972733992225 EUDAMED
- Basic UDI-DI
- 697273399010701FSL6D EUDAMED
- Direct Marketing DI
- 06972733992225 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Surgical Lights by HEYER Medical 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 | 697273399010701FSL6D | Class I | Active |
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Manufacturer
- Manufacturer
- HEYER Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014712
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f5239fdd-e256-4094-a66a-abfa967d75a7 61 fields · synced Jun 18, 2026