Identity
- Trade Name
- VITOM FDA UDI
- Generic Name
- Surgical microscope video camera, sterilizable FDA UDI
- Device Name
- 2D exoscopes EUDAMEDVITOM® Tel. 90° w Integ. Illuminator FDA UDI
- Model / Reference
- 20916025DA EUDAMEDFDA UDI
- Description
- VITOM® Tel. 90° w Integ. Illuminator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551324738 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551000381TM EUDAMED
- FDA Product Code
- EPT FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- Surgical microscope video camera, sterilizable 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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical microscope video camera, sterilizable
Vitom by Karl Storz GmbH & Co. KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical microscope video camera, sterilizable.
- Penumbra Coil 400 — PENUMBRA, INC. · Class II
- Stellar Exoscope — Guangdong Optomedic Technologies, Inc. · Class II
- VITOM — Karl Storz GmbH & Co. KG · Class I
- VITOM — Karl Storz GmbH & Co. KG · Class II
- VITOM — Karl Storz GmbH & Co. KG · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (2)
- FDA UDI 2d73bc90-b56e-4c5f-a450-6b7ad30763d0 33 fields · synced Jul 16, 2026
- EUDAMED 3606d423-d2c3-426e-96ff-92b90bebf87d 61 fields · synced Jul 16, 2026