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Brilliance OT
EUDAMEDClass I (EU MDR)
Ref 5080984Model ibT4035T, ibT4040T, ibT4045T, ibT4050T
Identity
- Trade Name
- Brilliance OT EUDAMED
- Device Name
- Surgical Binocular Loupes EUDAMED
- Model / Reference
- ibT4035T, ibT4040T, ibT4045T, ibT4050T EUDAMED5080984 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877825225 EUDAMED
- Basic UDI-DI
- 697259778IB010LG 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
Category: Surgical binoculars, reusable
Brilliance OT by Changzhou Sifary Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical binoculars, reusable.
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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 | 697259778IB010LG | 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 5ce8952a-d2cd-4b5f-8581-1e93531bd0f3 61 fields · synced Jul 15, 2026