Identity
- Trade Name
- IMAGE 1 S FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- White light camera heads EUDAMEDIMAGE1 S 4U FDA UDI
- Model / Reference
- TH120 EUDAMEDFDA UDI
- Description
- IMAGE1 S 4U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551370506 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551001644U5 EUDAMED
- FDA Product Code
- FET FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscope video camera
Image 1 S by Karl Storz GmbH & Co. KG — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (2)
- FDA UDI 6f573c43-b06f-4892-aa30-dfd46b522bc0 33 fields · synced Jul 9, 2026
- EUDAMED ccecfa0c-6079-4088-8eae-ffeca2ef2f85 61 fields · synced Jul 9, 2026