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PuraStat Nozzle System Type E 2.8ch-1600mm
EUDAMEDClass IIa (EU MDR)
Ref 634141Model 2.8ch-1600mm, 2.8ch-2200mm
Identity
- Trade Name
- PuraStat Nozzle System Type E 2.8ch-1600mm EUDAMED
- Device Name
- PuraStat Nozzle System Type E EUDAMED
- Model / Reference
- 2.8ch-1600mm, 2.8ch-2200mm EUDAMED634141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04996404613198 EUDAMED
- Basic UDI-DI
- 49964044X064SV EUDAMED
- EMDN Code
- G030299 DIGESTIVE ENDOSCOPY, HAEMOSTASIS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
PuraStat Nozzle System Type E 2.8ch-1600mm by TOP Corporation — Class IIa — 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 | 49964044X064SV | Class IIa | Active |
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Manufacturer
- Manufacturer
- TOP Corporation
- EUDAMED SRN
- JP-MF-000011618
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 99a7b207-b48a-47b0-88e8-ce287e72fe0b 61 fields · synced Jun 19, 2026