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Brilliance BP
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5080452Model ibG3035D, ibG3035S
Identity
- Trade Name
- Brilliance BP EUDAMEDEighteeth FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- Surgical Binocular Loupes EUDAMED
- Model / Reference
- ibG3035D, ibG3035S EUDAMED5080452 EUDAMEDibG3035S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941877804800 EUDAMEDFDA UDI
- Basic UDI-DI
- 697259778IB004LM EUDAMED
- FDA Product Code
- FSP FDA UDI
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMED
- GMDN Term
- Surgical binoculars, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical binoculars, reusable
Brilliance BP by Changzhou Sifary Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical binoculars, reusable.
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- Surgical Telescope — Xenosys Co., Ltd. · Class I
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697259778IB004LM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED ee7d7e7f-307a-471b-9fc0-73028443e251 61 fields · synced Sep 17, 2026
- FDA UDI 73b13b4f-5b6b-41e0-b28e-8cf2177a5950 32 fields · synced May 30, 2026