Identity
- Trade Name
- CapsoCloud EUDAMEDFDA UDI
- Generic Name
- Video capsule endoscopy system application software FDA UDI
- Device Name
- CapsoCloud EUDAMEDWeb-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and upload centers, also providing online video reviewing and reporting functionalities. FDA UDI
- Model / Reference
- CLD EUDAMEDCapsoCloud EUDAMED2 FDA UDI
- Description
- Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and upload centers, also providing online video reviewing and reporting functionalities. FDA UDI
Identifiers
- Catalog Number
- CLD FDA UDI
- Primary DI / UDI-DI
- 00867770000223 EUDAMEDFDA UDI
- Basic UDI-DI
- 086777000022CLDP3 EUDAMED
- 510(k) Number
- K192662 FDA UDI
- 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 I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1300 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CapsoCloud by CapsoVision, 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 | 086777000022CLDP3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 8b1b5325-5905-43a6-a417-c2a7df7b8f66 61 fields · synced Jun 19, 2026
- FDA UDI 61a99d91-19db-4e90-8b73-e7e067a8f9ac 36 fields · synced May 30, 2026