Identity
- Trade Name
- Capio™ EUDAMEDCapio SLIM FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- Capio™ SLIM Suture Capturing Device EUDAMEDSuture Capturing Device FDA UDI
- Model / Reference
- M0068318250 EUDAMEDFDA UDI
- Description
- Suture Capturing Device FDA UDI
Identifiers
- Catalog Number
- M0068318250 FDA UDI
- Primary DI / UDI-DI
- 08714729838005 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000447NE EUDAMED
- FDA Product Code
- PWI FDA UDI
- EMDN Code
- U1299 SINGLE-USE UROGENITAL INSTRUMENTATION (NON-ENDOSCOPIC) - OTHER EUDAMED
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4910 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Capio™ by Boston Scientific Corporation — 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 | 01915060000000000000447NE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 2353450c-0045-4dd6-a820-bcea83bc99d7 61 fields · synced Jun 18, 2026
- FDA UDI 2d3b33f1-7c8f-4879-86ca-1ee9d3aa3e37 34 fields · synced May 30, 2026