Identity
- Trade Name
- MICROSTAR EUDAMEDMICROSCOPE FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- MICROSCOPE EUDAMEDFDA UDI
- Model / Reference
- OM-100C EUDAMEDOM-100F2 EUDAMEDR01 FDA UDI
- Description
- MICROSCOPE FDA UDI
Identifiers
- Catalog Number
- U1OM100F2 FDA UDI
- Primary DI / UDI-DI
- B366U1OM100F2 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366U1MICROSCOPESX8 EUDAMED
- Direct Marketing DI
- B366U1OM100F2 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
- Spain 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
Microstar by EUSA Global Llc. — 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 | ++B366U1MICROSCOPESX8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EUSA Global Llc.
- EUDAMED SRN
- US-MF-000003607
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 72d606df-47f3-46f2-ad2b-f67c0bd9fec7 61 fields · synced Jul 30, 2026
- FDA UDI e7730ec0-fcbc-42a5-8b31-a6b6bfa2038d 36 fields · synced May 30, 2026