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Sterile Foley Catheter With Temperature Probe
EUDAMEDClass IIb (EU MDR)
Ref 24FrModel 6Fr、8Fr、10Fr、12Fr、14Fr、16Fr、18Fr、20Fr、22Fr、24Fr
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 EUDAMED24Fr EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971449610331 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 (1)
- EUDAMED c68e428b-7d6e-4bb0-825b-f286d1c5502c 61 fields · synced Jun 18, 2026