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LoFric Primo
EUDAMEDFDA UDIClass I (EU MDR)
Ref 41016Ref 41510Ref 41106Ref 41312Ref 41014Ref 41008Ref 41518Ref 41516Ref 41412
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" 10FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 8" 12FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 16" 14FR FDA UDISingle Use Urinary Catheter LoFric Primo Coudé 16" 16FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 6" 12FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 16" 08FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 16" 16FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 8" 06FR Paediatric FDA UDISingle Use Urinary Catheter LoFric Primo Coudé 16" 18FR FDA UDI
- Model / Reference
- 41016 EUDAMEDFDA UDI41510 EUDAMEDFDA UDI41106 EUDAMEDFDA UDI41312 EUDAMEDFDA UDI41014 EUDAMEDFDA UDI41008 EUDAMEDFDA UDI41518 EUDAMEDFDA UDI41516 EUDAMEDFDA UDI41412 EUDAMEDFDA UDI
- Description
- Single Use Urinary Catheter LoFric Primo Coudé 16" 10FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 8" 12FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 16" 14FR FDA UDISingle Use Urinary Catheter LoFric Primo Coudé 16" 16FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 6" 12FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 16" 08FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 16" 16FR FDA UDISingle Use Urinary Catheter LoFric Primo Nelaton 8" 06FR Paediatric FDA UDISingle Use Urinary Catheter LoFric Primo Coudé 16" 18FR FDA UDI
Identifiers
- Catalog Number
- 4151040 FDA UDI4131240 FDA UDI4101440 FDA UDI4151640 FDA UDI4141240 FDA UDI4100840 FDA UDI4101640 FDA UDI4110640 FDA UDI4151840 FDA UDI
- Primary DI / UDI-DI
- 07333387043029 EUDAMEDFDA UDI07333387043173 EUDAMEDFDA UDI07333387043043 EUDAMEDFDA UDI07333387043098 EUDAMEDFDA UDI07333387043012 EUDAMEDFDA UDI07333387042985 EUDAMEDFDA UDI07333387043210 EUDAMEDFDA UDI07333387043203 EUDAMEDFDA UDI07333387043159 EUDAMEDFDA UDI
- Basic UDI-DI
- 733338724101CV EUDAMED
- FDA Product Code
- EZD FDA UDI
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMEDU01010601 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 — 10 French FDA UDILength — 16 Inch FDA UDICatheter Gauge — 12 French FDA UDILength — 8 Inch FDA UDICatheter Gauge — 14 French FDA UDICatheter Gauge — 16 French FDA UDILength — 6 Inch FDA UDICatheter Gauge — 8 French FDA UDICatheter Gauge — 6 French FDA UDICatheter Gauge — 18 French 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 (27)
- EUDAMED 7492cd8e-eed7-479d-8a68-3297b8e574eb 61 fields · synced Oct 6, 2026
- EUDAMED 0a5a111e-187f-4202-93c2-17f3f8ede14d 61 fields · synced May 16, 2026
- EUDAMED 064b9eb5-17f6-48dc-88a2-7b02bd469977 61 fields · synced May 17, 2026
- EUDAMED 33ae2554-7ad4-41f1-ad2b-64352b48c6bc 61 fields · synced May 17, 2026
- EUDAMED 99dbb382-fec9-479a-a14d-d09bb2c2b14a 61 fields · synced May 17, 2026
- EUDAMED 7a7d8cf6-4e1d-41d3-b713-84bbde966bf1 61 fields · synced May 17, 2026
- EUDAMED 23b4e797-dbdf-4f23-83c4-82adaa7adf97 61 fields · synced May 18, 2026
- EUDAMED c2c0f742-264f-4d59-a482-f0ac5d770696 61 fields · synced May 18, 2026
- EUDAMED 6d22f9a8-2a4c-4ec0-b097-7f63333806ff 61 fields · synced May 18, 2026
- FDA UDI 5cc68098-4bc4-4751-9773-13ba556d6cfb 37 fields · synced May 24, 2026
- FDA UDI 85677547-bd51-4979-9600-0437795c3015 37 fields · synced May 25, 2026
- FDA UDI cafeec0b-156b-4a2a-8ce3-ed123f20d890 37 fields · synced May 27, 2026
- FDA UDI 593265f1-1962-4c39-a1af-b414db1272fc 37 fields · synced May 29, 2026
- FDA UDI 5864ed56-1360-4b5d-9652-bac2c7923118 37 fields · synced May 29, 2026
- FDA UDI 425978b5-45f8-4fcf-8200-0cea86f5937f 37 fields · synced May 30, 2026
- FDA UDI 6f0a340b-2bf4-4998-864f-4550847f1832 37 fields · synced May 30, 2026
- FDA UDI 8a503e61-1d8a-4028-8852-761126dca2c5 37 fields · synced May 30, 2026
- FDA UDI 41b8ae11-ca6c-44f6-b2c3-76a8d90ddc66 37 fields · synced May 30, 2026
- EUDAMED f92c0301-8bfd-4140-a0e2-ee005a47b10c 61 fields · synced Jul 9, 2026
- EUDAMED b69eb7cb-bdaf-40ff-9ad9-f9a9d9e83411 61 fields · synced Jul 10, 2026
- EUDAMED 7ba1cc7a-4bb2-4093-8dab-073e30176123 61 fields · synced Jul 14, 2026
- EUDAMED 6bdedfbb-dbf4-4d01-aa42-2a4940587a5b 61 fields · synced Jul 14, 2026
- EUDAMED 32061f7f-586d-4ca2-97b5-f8b1b6cd078c 61 fields · synced Jul 15, 2026
- EUDAMED cc4a97a3-46d8-4192-b9da-689c0d1fa75c 61 fields · synced Jul 22, 2026
- EUDAMED 98ba1fbf-69ae-4257-82bf-d19672942fd6 61 fields · synced Jul 23, 2026
- EUDAMED a1ee7017-db43-4fb7-9e61-cae682025d81 61 fields · synced Aug 2, 2026
- EUDAMED c6f8f026-ecf9-436e-b731-81698596ad37 61 fields · synced Aug 4, 2026