Identity
- Trade Name
- CapsoAccess EUDAMEDFDA UDI
- Generic Name
- Video capsule endoscopy system capsule FDA UDI
- Device Name
- CapsoAccess EUDAMEDCapsule Data Access System FDA UDI
- Model / Reference
- CDAS3 EUDAMED3 FDA UDI
- Description
- Capsule Data Access System FDA UDI
Identifiers
- Catalog Number
- 2668 FDA UDI
- Primary DI / UDI-DI
- 00867770000230 EUDAMEDFDA UDI
- Basic UDI-DI
- 086777000023CDAS3QG 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 I 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
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
CapsoAccess 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 | 086777000023CDAS3QG | 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 5b4a4ed4-ff8b-4a96-9034-494ffa9b7164 61 fields · synced Jul 9, 2026
- FDA UDI 41395993-fdb6-43d4-9185-27e34b346d2e 37 fields · synced May 30, 2026