Identity
- Trade Name
- Brilliance EUDAMEDEighteeth FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- Surgical Binocular Loupes EUDAMED
- Model / Reference
- ibG3545D, ibG3545S EUDAMED5080264 EUDAMEDibG3545S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975132954344 EUDAMEDFDA UDI
- Basic UDI-DI
- 697259778IB008LV 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 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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- 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 | 697259778IB008LV | 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 280e7c5e-e59f-4433-89fe-110aad7ff0d0 61 fields · synced Jul 9, 2026
- FDA UDI d3a5d413-eac2-4abc-906d-19bd04b2a21c 32 fields · synced May 30, 2026