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Extaro 300
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6033Model EXTARO 300Ref 305935-9740-000
Identity
- Trade Name
- EXTARO 300 EUDAMEDFDA UDIEXTARO® 300 FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- Surgical microscope EUDAMED
- Model / Reference
- EXTARO 300 EUDAMED6033 EUDAMEDFDA UDI305935-9740-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977585090051 EUDAMEDFDA UDI06977585090150 EUDAMED06909262060330 FDA UDI
- Basic UDI-DI
- 697758509_002_RA EUDAMED
- Direct Marketing DI
- 06977585090051 EUDAMED06977585090150 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 (4)
- EUDAMED 6c29d6c6-76ed-46df-907f-fa12e3ee14cf 61 fields · synced Jul 19, 2026
- FDA UDI f50630c8-c565-4986-8020-3a4f7a62e0b6 32 fields · synced May 30, 2026
- FDA UDI 3b23c9fc-a42d-454b-a5c4-0d04d7b56bd4 32 fields · synced May 30, 2026
- EUDAMED c09c93d1-a41e-4dd4-b80b-8cbcfd894ab0 61 fields · synced Jul 19, 2026