Identity
- Trade Name
- Swift Loop EUDAMEDFDA UDI
- Generic Name
- Surgical vessel loop FDA UDI
- Device Name
- Swift Loop with pledget EUDAMEDSwift Loop with Blunt Needle and Pledget. FDA UDI
- Model / Reference
- 1011058 EUDAMEDFDA UDI
- Description
- Swift Loop with Blunt Needle and Pledget. FDA UDI
Identifiers
- Catalog Number
- 1011058 FDA UDI
- Primary DI / UDI-DI
- D-1011058TN EUDAMED10817121000485 FDA UDI
- Basic UDI-DI
- B-1011058TN EUDAMED
- FDA Product Code
- GAE FDA UDI
- EMDN Code
- H900203 OCCLUSION TAPES, VASCULAR STRUCTURES EUDAMED
- GMDN Term
- Surgical vessel loop FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Swift Loop by Coroneo Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-1011058TN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Coroneo Inc.
- EUDAMED SRN
- CA-MF-000019141
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 35e32344-e900-4154-b374-ca249122fe65 61 fields · synced Jul 12, 2026
- FDA UDI 9fa9b4b7-093b-41a3-8844-1b0d2df6e9b8 36 fields · synced May 27, 2026