Identity
- Trade Name
- VITOM FDA UDI
- Generic Name
- Video camera surgical microscope system FDA UDI
- Device Name
- 3D exoscopes EUDAMEDVITOM® 3D FDA UDI
- Model / Reference
- TH200 EUDAMEDFDA UDI
- Description
- VITOM® 3D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551387245 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551001572U5 EUDAMED
- FDA Product Code
- EPT FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- Video camera surgical microscope system 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 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
No
FDA UDI
Category: Video camera surgical microscope system
Vitom by Karl Storz GmbH & Co. KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (2)
- FDA UDI 54f0b272-0401-4219-ac31-8a2c4fe11ab2 33 fields · synced Jul 28, 2026
- EUDAMED 32f6c891-ba32-4c95-b1e9-4e12a2794dad 61 fields · synced Jul 28, 2026