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Niti-S Hot SPAXUS Stent & Electrocautery Stent Delivery System
EUDAMEDClass IIb (EU MDR)
Ref HSS0802FW
Identity
- Trade Name
- Niti-S Hot SPAXUS Stent & Electrocautery Stent Delivery System EUDAMED
- Device Name
- Niti-S Hot SPAXUS Stent & Electrocautery Stent Delivery System EUDAMED
- Model / Reference
- HSS0802FW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809643750356 EUDAMED
- Basic UDI-DI
- B-08809643750356 EUDAMED
- EMDN Code
- P0502 BILIARY AND PANCREATIC PROSTHESES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Niti-S Hot SPAXUS Stent & Electrocautery Stent Delivery System by Taewoong Medical 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-08809643750356 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Taewoong Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000007515
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6e281abb-0bce-4c24-9e3a-2c4e88eb809e 61 fields · synced Oct 7, 2026