Identity
- Trade Name
- CapsoView EUDAMEDFDA UDI
- Generic Name
- Video capsule endoscopy system application software FDA UDI
- Device Name
- CapsoView EUDAMEDSoftware FDA UDI
- Model / Reference
- CVV EUDAMED3 FDA UDI
- Description
- Software FDA UDI
Identifiers
- Catalog Number
- 2759 FDA UDI
- Primary DI / UDI-DI
- 00867770000216 EUDAMEDFDA UDI
- Basic UDI-DI
- 086777000021CVVQW EUDAMED
- FDA Product Code
- NEZ FDA UDI
- EMDN Code
- G030701 GASTROINTESTINAL IMAGING DIAGNOSTIC DEVICES EUDAMED
- GMDN Term
- Video capsule endoscopy system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1300 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CapsoView by CapsoVision, Inc. — Class IIa — 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 | 086777000021CVVQW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CapsoVision, Inc.
- EUDAMED SRN
- US-MF-000008446
- Authorised Representative
- MedDevConsult GmbH DE-AR-000005877
Sources (2)
- EUDAMED 71192a50-14e6-4440-adb4-33fe8c97cb46 61 fields · synced Jun 17, 2026
- FDA UDI 58fb39ca-28c0-4179-bd16-9ba7842408cd 36 fields · synced May 30, 2026