Identity
- Trade Name
- PES Pilot HDpro EUDAMEDOTOPRONT FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- Portable Endoscopy System EUDAMED
- Model / Reference
- PES Pilot HDpro EUDAMEDFDA UDI350035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260154546663 EUDAMEDFDA UDI
- Basic UDI-DI
- 426015454PESPL202121101A3 EUDAMED
- FDA Product Code
- FWC FDA UDI
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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: Endoscope video camera
Otopront by Happersberger Otopront GmbH — 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
- Happersberger Otopront GmbH
Sources (2)
- FDA UDI b5f61c62-dd16-4ede-b92f-c77e14ca7d11 32 fields · synced Jul 10, 2026
- EUDAMED cbdd0875-aa6c-48b5-a0f7-ee990ef3a279 61 fields · synced Jul 10, 2026