Identity
- Trade Name
- EXTARO 300 EUDAMEDFDA UDIEXTARO® 300 FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- Surgical microscope EUDAMEDNo device description FDA UDI
- Model / Reference
- EXTARO 300 EUDAMED6034 EUDAMEDFDA UDI
- Description
- No device description FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977585090099 EUDAMEDFDA UDI06909262060347 FDA UDI
- Basic UDI-DI
- 697758509_002_RA EUDAMED
- Direct Marketing DI
- 06977585090099 EUDAMED
- FDA Product Code
- EPT FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- General-purpose surgical microscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4700 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 UDIFDA 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
MR Conditional FDA UDI
Extaro 300 by Carl Zeiss Meditec (Suzhou) Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697758509_002_RA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000044920
- Authorised Representative
- Carl Zeiss Meditec AG DE-AR-000007733
Sources (3)
- EUDAMED 4f4abb5d-d766-460a-90f7-34f198cbe7dc 61 fields · synced Jun 18, 2026
- FDA UDI 78283111-0017-4978-b3e0-9476ad7e3d52 32 fields · synced May 30, 2026
- FDA UDI 54429c65-033b-497c-bdff-fdd660921dcf 33 fields · synced May 30, 2026