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Hemodialysis Catheter Kit Double Lumen (Curved) - 11.5 FR x 13 cm
EUDAMEDClass IIa (EU MDR)
Ref MI/CA/01-000-EModel Hemodialysis Catheter Kit - Single/Double/Triple Lumen (Straight & Curved)
Identity
- Trade Name
- Hemodialysis Catheter Kit Double Lumen (Curved) - 11.5 FR x 13 cm EUDAMED
- Device Name
- Hemodialysis Catheter EUDAMED
- Model / Reference
- Hemodialysis Catheter Kit - Single/Double/Triple Lumen (Straight & Curved) EUDAMEDMI/CA/01-000-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904476803504 EUDAMED
- Basic UDI-DI
- 89044768R023N EUDAMED
- Direct Marketing DI
- 08904476803504 EUDAMED
- EMDN Code
- F900201 TEMPORARY HEMODIALYSIS CATHETERS AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hemodialysis Catheter Kit Double Lumen (Curved) - 11.5 FR x 13 cm by Mais India Medical Devices Pvt. Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 89044768R023N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mais India Medical Devices Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000021842
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 5ba9b0a7-8432-435a-9892-d178811358d8 61 fields · synced Oct 6, 2026