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Silicone Foley Catheters with Temperature probe for Single Use
EUDAMEDClass IIb (EU MDR)
Ref /
Identity
- Device Name
- Silicone Foley Catheters with Temperature probe for Single Use EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948097052530 EUDAMED
- Basic UDI-DI
- B-06948097052530 EUDAMED
- EMDN Code
- U0103 URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone Foley Catheters with Temperature probe for Single Use by Haiyan Kangyuan Medical Instrument Co., Ltd. — Class IIb — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06948097052530 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Haiyan Kangyuan Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001532
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 59dfac5d-b3a2-4126-bf0b-d4912ea36c74 61 fields · synced Oct 8, 2026