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OT light/Examination light
EUDAMEDClass I (EU MDR)
Ref BT310A ,BT681E-500,BT681E-500/700
Identity
- Device Name
- OT light/Examination light EUDAMED
- Model / Reference
- BT310A ,BT681E-500,BT681E-500/700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972712690463 EUDAMED
- Basic UDI-DI
- 697271269BT310BT681FQ EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
OT light/Examination light by Better medical technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697271269BT310BT681FQ | Class I | Unknown |
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Manufacturer
- Manufacturer
- Better medical technology Co., Ltd
- EUDAMED SRN
- CN-MF-000001280
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 7ec483bf-1525-4eb0-af28-c76f9e36a784 61 fields · synced Jun 18, 2026
- EUDAMED 7ec483bf-1525-4eb0-af28-c76f9e36a784-1 61 fields · synced Jun 10, 2026