Identity
- Trade Name
- Videoscope Processor VSP-2000 EUDAMEDMACHIDA FDA UDI
- Generic Name
- Endoscopic control/video-imaging system FDA UDI
- Device Name
- Videoscope Processor EUDAMED
- Model / Reference
- VSP-2000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04580137733041 EUDAMEDFDA UDI
- Basic UDI-DI
- 458013773D00143 EUDAMED
- 510(k) Number
- K821182 FDA UDI
- FDA Product Code
- EQN FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Endoscopic control/video-imaging system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Market of Registration
- Spain 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
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Videoscope Processor VSP-2000 by Machida Endoscope Co., Ltd. — 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 | 458013773D00143 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Machida Endoscope Co., Ltd.
- EUDAMED SRN
- JP-MF-000008990
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2cfa8b92-eef3-4fb9-af29-68c66f5d9fb5 61 fields · synced Jul 15, 2026
- FDA UDI 3383b985-07fd-44ee-9412-45dd1a5bda9e 34 fields · synced May 29, 2026