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LoFric Insti-Cath
EUDAMEDClass I (EU MDR)
Ref 40712Ref 40714Ref 40708Ref 40710Ref 40810
Identity
- Trade Name
- LoFric Insti-Cath EUDAMED
- Device Name
- Single use hydrophilic urinary catheter for bladder instillation EUDAMED
- Model / Reference
- 40712 EUDAMED40714 EUDAMED40708 EUDAMED40710 EUDAMED40810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333387041476 EUDAMED07333387041681 EUDAMED07333387041056 EUDAMED07333387041261 EUDAMED07333387042107 EUDAMED
- Basic UDI-DI
- 733338724102CX EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
LoFric Insti-Cath by Wellspect HealthCare — Class I — MDR — listed in EUDAMED — 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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 733338724102CX | Class I | Active |
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Manufacturer
- Manufacturer
- Wellspect HealthCare
- EUDAMED SRN
- SE-MF-000026271
Sources (6)
- EUDAMED f789c0d1-624b-441a-a65d-4d9bd5302f62 61 fields · synced Aug 1, 2026
- EUDAMED 1650b473-d576-49a5-b0bb-2745b4ca0130 61 fields · synced Jul 11, 2026
- EUDAMED a94b9d08-2520-46ec-ac68-8823b6b73e67 61 fields · synced Jul 15, 2026
- EUDAMED b8fb415e-71c3-4ceb-a715-f09727398ace 61 fields · synced Jul 26, 2026
- EUDAMED cc7048de-528b-40b8-8789-84f909f27f70 61 fields · synced Jul 26, 2026
- EUDAMED 223d5f47-a13a-4912-a0ad-41d22fdead33 61 fields · synced Aug 1, 2026