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Apical Negative Pressure Irrigation and Activation Kits
EUDAMEDClass I (EU MDR)
Ref 9542ACT
Identity
- Trade Name
- Apical Negative Pressure Irrigation and Activation Kits EUDAMED
- Device Name
- Apical Negative Pressure Irrigation and Activation Kits EUDAMED
- Model / Reference
- 9542ACT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16973163110064 EUDAMED
- Basic UDI-DI
- 697316311ANPIAK00002CB EUDAMED
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Apical Negative Pressure Irrigation and Activation Kits by Suzhou Pac-Dent Technology Co., Ltd. — Class I — 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 | 697316311ANPIAK00002CB | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Pac-Dent Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021642
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED b919fc56-4443-4d2d-86a4-2f0f2c76bffd 61 fields · synced Jun 18, 2026