Identity
- Trade Name
- CapsoCam Plus FDA UDI
- Generic Name
- Video capsule endoscopy system capsule FDA UDI
- Device Name
- CapsoCam Plus EUDAMEDConvenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit FDA UDI
- Model / Reference
- SV-3KIT EUDAMEDFDA UDICapsoCam Plus EUDAMED
- Description
- Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit FDA UDI
Identifiers
- Catalog Number
- 2795 FDA UDI
- Primary DI / UDI-DI
- 00867770000261 EUDAMEDFDA UDI
- Basic UDI-DI
- 086777000026SV3KITBT EUDAMED
- FDA Product Code
- NEZ FDA UDI
- EMDN Code
- G030701 GASTROINTESTINAL IMAGING DIAGNOSTIC DEVICES EUDAMED
- GMDN Term
- Video capsule endoscopy system capsule FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1300 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
CapsoCam Plus 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 | 086777000026SV3KITBT | 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 e840debf-7c18-417a-bb2c-9774c28fb268 61 fields · synced Jun 8, 2026
- FDA UDI f7115e77-03cb-43be-9bc9-db8c6ab58a30 36 fields · synced May 30, 2026