Identity
- Trade Name
- LoFric Primo EUDAMEDLoFric® Primo™ FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Single use hydrophilic urinary catheter for intermittent urinary catheterization EUDAMEDSingle Use Urinary Catheter LoFric Primo Coudé 16" 14FR FDA UDI
- Model / Reference
- 41514 EUDAMEDFDA UDI
- Description
- Single Use Urinary Catheter LoFric Primo Coudé 16" 14FR FDA UDI
Identifiers
- Catalog Number
- 4151440 FDA UDI
- Primary DI / UDI-DI
- 07333387043197 EUDAMEDFDA UDI
- Basic UDI-DI
- 733338724101CV EUDAMED
- FDA Product Code
- EZD FDA UDI
- EMDN Code
- U01010601 TIEMANN CATHETERS, SELF-LUBRICATING EUDAMED
- GMDN Term
- Single-administration urethral catheterization kit, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Sweden 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 14 French FDA UDILength — 16 Inch FDA UDI
LoFric Primo by Wellspect HealthCare — 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 | 733338724101CV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wellspect HealthCare
- EUDAMED SRN
- SE-MF-000026271
Sources (3)
- EUDAMED 04a60ea2-338c-4c3c-b5c2-a6c29edc12be 61 fields · synced Jun 18, 2026
- FDA UDI 8714d4b7-47f5-49fe-bb9a-35f9fba35a6d 37 fields · synced May 30, 2026
- EUDAMED 92026127-b7ab-4dba-a161-427d7df5c7d9 61 fields · synced Jun 11, 2026