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Surgical Lights
EUDAMEDClass I (EU MDR)
Ref 118000038Model OL9550Ref 118000135Ref 118000003Ref 118000132Ref 118000068Model OLM9550/OLM9680Ref 118000113Ref 118000133Ref 118000053Ref 118000162Ref 118000020
Identity
- Trade Name
- Surgical Lights EUDAMED
- Device Name
- Surgical Lights EUDAMED
- Model / Reference
- OL9550 EUDAMED118000038 EUDAMED118000135 EUDAMED118000003 EUDAMED118000132 EUDAMEDOLM9550/OLM9680 EUDAMED118000068 EUDAMED118000113 EUDAMED118000133 EUDAMED118000053 EUDAMED118000162 EUDAMED118000020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972733990382 EUDAMED06972733991358 EUDAMED06972733993321 EUDAMED06972733991327 EUDAMED06972733990689 EUDAMED06972733991136 EUDAMED06972733991334 EUDAMED06972733990535 EUDAMED06972733992010 EUDAMED06972733992027 EUDAMED
- Basic UDI-DI
- 697273399010701FSL6D EUDAMED697273399010702MSL7P EUDAMED
- Direct Marketing DI
- 06972733990382 EUDAMED06972733991358 EUDAMED06972733993321 EUDAMED06972733991327 EUDAMED06972733990689 EUDAMED06972733991136 EUDAMED06972733991334 EUDAMED06972733990535 EUDAMED06972733992010 EUDAMED06972733992027 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMEDZ12010702 MOBILE 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 (10)
- EUDAMED 25244027-8505-421b-afa4-ca426e7905ab 61 fields · synced Aug 3, 2026
- EUDAMED 17477efa-1261-4f0b-b5c0-5a1acd535249 61 fields · synced May 11, 2026
- EUDAMED e1719568-2328-4be1-b007-58f4c0da32ec 61 fields · synced May 16, 2026
- EUDAMED b58f03f6-154e-4731-acc4-76ad719cf0ce 61 fields · synced May 17, 2026
- EUDAMED dd295351-2d79-4ee8-9c80-31cb645e6b50 61 fields · synced May 17, 2026
- EUDAMED 3e8d0671-8f38-4813-8074-ca38a0f475ee 61 fields · synced May 17, 2026
- EUDAMED 9a775925-f49d-41bb-8ee1-d075c1f02945 61 fields · synced May 17, 2026
- EUDAMED b46b5aad-1c77-4076-85da-54d90ad6521c 61 fields · synced May 18, 2026
- EUDAMED a89bec87-99ad-48df-badd-3b59b33c4711 61 fields · synced May 18, 2026
- EUDAMED 06bfea8f-7dc8-43bb-badc-78864df6aedb 61 fields · synced May 18, 2026