← Back to catalogue
Apical Negative Pressure Irrigation and Activation Kits
EUDAMEDClass I (EU MDR)
Ref 9542LTA
Identity
- Trade Name
- Apical Negative Pressure Irrigation and Activation Kits EUDAMED
- Device Name
- Apical Negative Pressure Irrigation and Activation Kits EUDAMED
- Model / Reference
- 9542LTA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16973163110088 EUDAMED
- Basic UDI-DI
- 697316311ANPIAK00001C9 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 | 697316311ANPIAK00001C9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 a7f61278-018d-4db3-8457-14187e23909b 61 fields · synced Jun 19, 2026