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TPU Curan Hydrophilic Coated
EUDAMEDClass I (EU MDR)
Ref THF12Model Curan Hydrophilic Coated TPU
Identity
- Trade Name
- TPU Curan Hydrophilic Coated EUDAMED
- Device Name
- Curan Hydrophilic Coated TPU EUDAMED
- Model / Reference
- Curan Hydrophilic Coated TPU EUDAMEDTHF12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08718657212074 EUDAMED
- Basic UDI-DI
- 871865721TPU-THC8H EUDAMED
- Direct Marketing DI
- 08718657212074 EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
TPU Curan Hydrophilic Coated by Curan Medical BV — Class I — 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 | 871865721TPU-THC8H | Class I | Active |
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Manufacturer
- Manufacturer
- Curan Medical BV
- EUDAMED SRN
- NL-MF-000022827
Sources (1)
- EUDAMED 67409e16-9f1f-4c48-a6c3-96209e38e6f9 61 fields · synced Jun 18, 2026