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Brilliance OT
EUDAMEDClass I (EU MDR)
Ref 5080992Model ibT7235T, ibT7240T, ibT7245T, ibT7250T
Identity
- Trade Name
- Brilliance OT EUDAMED
- Device Name
- Surgical Binocular Loupes EUDAMED
- Model / Reference
- ibT7235T, ibT7240T, ibT7245T, ibT7250T EUDAMED5080992 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877825300 EUDAMED
- Basic UDI-DI
- 697259778IB012LL EUDAMED
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Brilliance OT by Changzhou Sifary 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 Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697259778IB012LL | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED e7c9553a-eed7-4a74-a614-c1c08526da23 61 fields · synced Jun 18, 2026