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Powder Jet Scaler
EUDAMEDClass I (EU MDR)
Ref IJet 2SModel iJet, iJet S, IJet 2SRef iJet
Identity
- Trade Name
- Powder Jet Scaler EUDAMED
- Device Name
- Powder Jet Scaler EUDAMED
- Model / Reference
- iJet, iJet S, IJet 2S EUDAMEDIJet 2S EUDAMEDiJet EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971560456733 EUDAMED06971560452490 EUDAMED
- Basic UDI-DI
- 697156045PJHSB EUDAMED
- Direct Marketing DI
- 06971560456733 EUDAMED06971560452490 EUDAMED
- EMDN Code
- Z12119006 DENTAL CLEANING/WASHING HANDPIECE EQUIPMENTS 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
Powder Jet Scaler by Guilin Refine Medical Instrument 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 | 697156045PJHSB | Class I | Active |
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Manufacturer
- Manufacturer
- Guilin Refine Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012204
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (2)
- EUDAMED 301dc656-9300-4a63-8b35-f9a731750749 61 fields · synced Oct 6, 2026
- EUDAMED c15cd328-cc86-454d-9f84-0d3b1c23473f 61 fields · synced May 19, 2026