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Fluorescence Mode
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 000000-2165-387510(k) K171007
Identity
- Trade Name
- Fluorescence Mode EUDAMEDFDA UDI
- Generic Name
- Dental surgical microscope FDA UDI
- Device Name
- Fluorescence Mode EUDAMED
- Model / Reference
- 000000-2165-387 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 000000-2165-387 FDA UDI
- Primary DI / UDI-DI
- 06977585090143 EUDAMEDFDA UDI06909262100043 FDA UDI
- Basic UDI-DI
- 697758509_003_RD EUDAMED
- 510(k) Number
- K171007 FDA UDI
- FDA Product Code
- NBL FDA UDI
- EMDN Code
- Z1201118099 INSTRUMENTS FOR OPERATIVE MICROSCOPY - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Dental surgical microscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1745 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Fluorescence Mode by Carl Zeiss Meditec (Suzhou) Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171007 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697758509_003_RD | Class I | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000044920
- FDA Applicant
- Carl Zeiss Suzhou Co., Ltd.
- Authorised Representative
- Carl Zeiss Meditec AG DE-AR-000007733
Sources (4)
- EUDAMED c122ea0f-c2ee-460d-b724-e8f8c02a2a21 85 fields · synced Jun 18, 2026
- FDA UDI 19aa5bc1-70f1-4fc0-93ad-ecf572afa0df 33 fields · synced May 30, 2026
- FDA UDI 83050910-b412-4728-b6c3-f4b9931ff3e7 34 fields · synced May 30, 2026
- FDA 510(k) K171007 1 fields · synced May 18, 2026