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Brilliance BP
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5080412Model ibG3045D, ibG3045SRef 5080440Model ibG3550D, ibG3550SRef 5080446Ref 5080447Ref 5080442
Identity
- Trade Name
- Brilliance BP EUDAMEDEighteeth FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- Surgical Binocular Loupes EUDAMED
- Model / Reference
- ibG3045D, ibG3045S EUDAMED5080412 EUDAMEDibG3550D, ibG3550S EUDAMED5080440 EUDAMED5080446 EUDAMED5080447 EUDAMED5080442 EUDAMEDibG3550S FDA UDIibG3550D FDA UDIibG3045S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941877804909 EUDAMEDFDA UDI06941877809843 EUDAMEDFDA UDI06941877809829 EUDAMEDFDA UDI06941877809898 EUDAMEDFDA UDI06941877809881 EUDAMEDFDA UDI
- Basic UDI-DI
- 697259778IB002LH EUDAMED697259778IB006LR 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
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Also classified as Surgical binoculars, reusable.
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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 | 697259778IB002LH | 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 (10)
- EUDAMED 84487ae4-fe33-40a3-9bb7-d985018e4a84 61 fields · synced Jul 22, 2026
- FDA UDI 3040868b-9107-4f3d-a1f7-f21eeb01c196 32 fields · synced May 27, 2026
- FDA UDI 86826c20-c408-4e81-8ed2-35d5dd063a40 32 fields · synced May 30, 2026
- FDA UDI 67a81ba8-aa79-4ab3-ac4e-ff936a733913 32 fields · synced May 30, 2026
- FDA UDI cbef02be-f393-4828-815b-1a669ca4aa82 32 fields · synced May 30, 2026
- FDA UDI 3aaa3993-58b5-45ef-a690-94e43bd09850 32 fields · synced May 30, 2026
- EUDAMED 87902349-4180-40d4-9853-d78ff1b8adae 61 fields · synced Jul 8, 2026
- EUDAMED 06037902-006e-463d-9f71-20e47b82a007 61 fields · synced Jul 11, 2026
- EUDAMED bdd4f55d-cda6-4a88-aba5-5a748bf7d120 61 fields · synced Jul 16, 2026
- EUDAMED fb522099-e12a-42da-8653-71124636e83a 61 fields · synced Jul 22, 2026