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Sterile Foley Catheter With Temperature Probe
EUDAMEDClass IIb (EU MDR)
Ref 12FrModel 6Fr、8Fr、10Fr、12Fr、14Fr、16Fr、18Fr、20Fr、22Fr、24FrRef 22FrRef 6FrRef 18FrRef 8FrRef 10Fr
Identity
- Trade Name
- Sterile Foley Catheter With Temperature Probe EUDAMED
- Device Name
- Sterile Foley Catheter With Temperature Probe EUDAMED
- Model / Reference
- 6Fr、8Fr、10Fr、12Fr、14Fr、16Fr、18Fr、20Fr、22Fr、24Fr EUDAMED12Fr EUDAMED22Fr EUDAMED6Fr EUDAMED18Fr EUDAMED8Fr EUDAMED10Fr EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971449610263 EUDAMED06971449610324 EUDAMED06971449611758 EUDAMED06971449610294 EUDAMED06971449610249 EUDAMED06971449610256 EUDAMED
- Basic UDI-DI
- 697144961TFCU3 EUDAMED
- EMDN Code
- U0103 URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Foley Catheter With Temperature Probe by Shenzhen Envisen Industry Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697144961TFCU3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Envisen Industry Co., Ltd.
- EUDAMED SRN
- CN-MF-000010838
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED 726735aa-fcf5-4d73-9612-0df7af6d0e78 61 fields · synced Sep 17, 2026
- EUDAMED 9141d09c-1175-4fd7-9d6c-bf03aa38e490 61 fields · synced May 16, 2026
- EUDAMED 9085fee6-0cb8-4085-a2d9-0138e456888e 61 fields · synced May 17, 2026
- EUDAMED 7b2017b5-cdc6-4994-8bb5-e3aeede57be9 61 fields · synced May 17, 2026
- EUDAMED b8f5e339-83db-40fe-bc89-e0154ff53a61 61 fields · synced May 18, 2026
- EUDAMED 784233af-e101-47d8-99e6-24a84b9a135b 61 fields · synced May 18, 2026