Identity
- Trade Name
- Irrigation Needle for Single Use EUDAMED
- Device Name
- Irrigation Needle for Single Use EUDAMED
- Model / Reference
- D12122 EUDAMEDD12725 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949236207927 EUDAMED06949236207910 EUDAMED
- Basic UDI-DI
- 69492362N008QU EUDAMED
- EMDN Code
- A010602 DENTAL IRRIGATION NEEDLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Irrigation Needle for Single Use by Berpu Medical Technology Co., Ltd — Class I — 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 | 69492362N008QU | Class I | Active |
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Manufacturer
- Manufacturer
- Berpu Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000012430
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED dc626d7b-9224-404e-ae7d-269809308621 61 fields · synced Aug 2, 2026
- EUDAMED 9d709243-e65b-449f-837f-01fa602ac809 61 fields · synced May 17, 2026
- EUDAMED 832d47e8-85b1-4e47-be95-a8e3206fece5 61 fields · synced Jun 19, 2026