Identity
- Trade Name
- Catheter Mount EUDAMED
- Device Name
- Catheter Mount EUDAMED
- Model / Reference
- ETE-15 EUDAMEDETC-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970531331830 EUDAMED26970531331837 EUDAMED
- Basic UDI-DI
- 697053133cmbcVH EUDAMED
- Direct Marketing DI
- 16970531331830 EUDAMED26970531331837 EUDAMED
- EMDN Code
- R020299 MOUNT CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
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
Catheter Mount by Shaoxing Undis Medical Technology Co., Ltd — Class IIa — CE/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 | 697053133cmbcVH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Undis Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000002187
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED f60d9000-fc99-4181-adf4-acc29b27aba0 61 fields · synced Oct 6, 2026
- EUDAMED f0328d81-1c98-4501-a301-79077415c0a2 61 fields · synced May 17, 2026