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Brilliance 48° Pro
EUDAMEDClass I (EU MDR)
Ref 5080769Model ibT5035+, ibT5040+, ibT5045, ibT5045+, ibT5050+
Identity
- Trade Name
- Brilliance 48° Pro EUDAMED
- Device Name
- Surgical Binocular Loupes EUDAMED
- Model / Reference
- ibT5035+, ibT5040+, ibT5045, ibT5045+, ibT5050+ EUDAMED5080769 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877813147 EUDAMED
- Basic UDI-DI
- 697259778IB009LX EUDAMED
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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 48° Pro by Changzhou Sifary Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697259778IB009LX | 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 894b4340-c27b-4862-ae86-5f96883acc5e 61 fields · synced Jul 19, 2026