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 Nelaton 6" 14FR FDA UDI
- Model / Reference
- 41414 EUDAMEDFDA UDI
- Description
- Single Use Urinary Catheter LoFric Primo Nelaton 6" 14FR FDA UDI
Identifiers
- Catalog Number
- 4141440 FDA UDI
- Primary DI / UDI-DI
- 07333387043166 EUDAMEDFDA UDI
- Basic UDI-DI
- 733338724101CV EUDAMED
- FDA Product Code
- EZD FDA UDI
- EMDN Code
- U01010501 NELATON 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Catheter Gauge — 14 French FDA UDILength — 6 Inch FDA UDI
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
LoFric Primo by Wellspect HealthCare — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- TruCath Oasis — H R Pharmaceuticals, Inc. · Class II
- SmoothCath™ — GELİŞİM MEDİKAL TIBBİ MALZ. PAZ. SAN. VE TİC. LTD. ŞTİ. · Class I
- PVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Class II
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- CompactCath Nelaton, Female, 14 Fr/Ch, 19cm — Lentismed d.o.o. · Class I
- GoldCath — DEMERSAN BIYOTEKNOLOJI İMALAT SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIa
- Disposable Intermittent Catheter — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wellspect HealthCare
- EUDAMED SRN
- SE-MF-000026271
Sources (3)
- EUDAMED 2220cd36-0604-49be-9156-62e460f9eaee 61 fields · synced Jun 19, 2026
- FDA UDI 5c884b38-0659-425c-922d-1c7f0b9d957d 37 fields · synced May 30, 2026
- EUDAMED ab511c5a-708c-4765-b53b-d3a88afe4902 61 fields · synced Jun 19, 2026