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Brilliance
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5080103Model ibG3050D, ibG3050SRef 5080975Model ibG3035T, ibG3040T, ibG3045T, ibG3050TRef 5080978Ref 5080972Model ibG2535T, ibG2540T, ibG2545T, ibG2550TRef 5080314Model ibG3550D, ibG3550SRef 5080973Ref 5080302Ref 5080304Ref 5080320Ref 5080316Ref 5080318Ref 5080306
Identity
- Trade Name
- Brilliance EUDAMEDBrilliance T EUDAMEDEighteeth FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- Surgical Binocular Loupes EUDAMED
- Model / Reference
- ibG3050D, ibG3050S EUDAMED5080103 EUDAMEDibG3035T, ibG3040T, ibG3045T, ibG3050T EUDAMED5080975 EUDAMED5080978 EUDAMEDibG2535T, ibG2540T, ibG2545T, ibG2550T EUDAMED5080972 EUDAMEDibG3550D, ibG3550S EUDAMED5080314 EUDAMED5080973 EUDAMED5080302 EUDAMED5080304 EUDAMED5080320 EUDAMED5080316 EUDAMED5080318 EUDAMED5080306 EUDAMEDibG3550S FDA UDIibG3550D FDA UDIibG3050S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975132955693 EUDAMEDFDA UDI06975132954559 EUDAMEDFDA UDI06975132954603 EUDAMEDFDA UDI06975132954535 EUDAMEDFDA UDI06975132954610 EUDAMEDFDA UDI06975132954542 EUDAMEDFDA UDI06975132954597 EUDAMEDFDA UDI06975132954627 EUDAMEDFDA UDI06941877825133 EUDAMED06941877825164 EUDAMED06941877825102 EUDAMED06941877825119 EUDAMED
- Basic UDI-DI
- 697259778IB003LK EUDAMED697259778IB015LS EUDAMED697259778IB013LN 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 EUDAMEDCzechia 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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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 | 697259778IB003LK | 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 (20)
- EUDAMED 8c0ca292-ba6c-437c-a12c-a5e6cb2859ce 61 fields · synced Sep 18, 2026
- FDA UDI 0ede30e5-9d71-4654-b653-c58c9f16d193 32 fields · synced May 22, 2026
- FDA UDI fc79292e-8ccb-42f1-bfc3-5dfe51b1c285 32 fields · synced May 22, 2026
- FDA UDI 1c35cdf2-68ad-4ae8-8f60-0cb14a9036f6 32 fields · synced May 24, 2026
- FDA UDI 71f9de13-cd14-4c18-9a7d-d1a9bdbd4b88 32 fields · synced May 29, 2026
- FDA UDI cc696125-40e9-4f07-8eba-93bebcb4e4fb 32 fields · synced May 29, 2026
- FDA UDI e48e96b5-c70f-4106-ba0b-3569f22fea86 32 fields · synced May 29, 2026
- FDA UDI f9586f07-d05f-4848-9cad-f716179a68f3 32 fields · synced May 30, 2026
- FDA UDI aac51ddf-6905-4116-9650-98f7cb3b2056 32 fields · synced May 30, 2026
- EUDAMED 94553f82-a6ae-4b29-b2d9-623e815d40a2 61 fields · synced Jul 9, 2026
- EUDAMED 4f4ca921-0523-41f6-a76c-8226fe3c017d 61 fields · synced Jul 10, 2026
- EUDAMED 59743565-ac81-431b-825e-676a34347a56 61 fields · synced Jul 10, 2026
- EUDAMED 25d39d5a-ddcc-4483-ac42-264b5138c542 61 fields · synced Jul 12, 2026
- EUDAMED cae12d21-c7e7-4a72-9e96-c8f4ef59aab6 61 fields · synced Jul 13, 2026
- EUDAMED eac77c42-b6a9-4405-b1b4-de73d14a7491 61 fields · synced Jul 13, 2026
- EUDAMED eab75e56-ff56-4809-a6d1-69e7da518c9e 61 fields · synced Jul 17, 2026
- EUDAMED da77b867-35df-4daa-b561-685a43dab5e2 61 fields · synced Jul 20, 2026
- EUDAMED 09ca78d3-0734-48a7-9246-46674fe8e3a4 61 fields · synced Jul 31, 2026
- EUDAMED 7d245504-9637-4643-8883-4877ac220491 61 fields · synced Aug 2, 2026
- EUDAMED 8084e552-7a1e-4762-b818-e768a02d15d5 61 fields · synced Sep 18, 2026