Identity
- Trade Name
- Digital Capture EUDAMEDPentax of America FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- Digital Capture EUDAMEDCapture Module FDA UDI
- Model / Reference
- 9380 EUDAMEDFDA UDI
- Description
- Capture Module FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333248117 EUDAMEDFDA UDI
- Basic UDI-DI
- 496133303938034 EUDAMED
- Direct Marketing DI
- 04961333248117 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Z119007 IMAGE ACQUISITION MODULES EUDAMED
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 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
Yes
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
Yes
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
Digital Capture by PENTAX of America, Inc. — 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 | 496133303938034 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PENTAX of America Inc.
- EUDAMED SRN
- US-MF-000008135
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (2)
- EUDAMED 373b202c-f0f0-4858-828d-c910cc67b329 61 fields · synced Jul 24, 2026
- FDA UDI c39e1010-d1a2-45c4-b545-cf187a081f8a 33 fields · synced May 30, 2026