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Disposable Dental Irrigation
EUDAMEDClass I (EU MDR)
Ref 27G-B25Model CS01,CS02
Identity
- Trade Name
- Disposable Dental Irrigation EUDAMED
- Device Name
- Dental impression material syringe EUDAMED
- Model / Reference
- CS01,CS02 EUDAMED27G-B25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454013915 EUDAMED
- Basic UDI-DI
- 69544540DIMS001Q2 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Disposable Dental Irrigation by Huanghua Promisee Dental 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 | 69544540DIMS001Q2 | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 01a99b90-433b-424b-987f-7ffe44f7bc01 61 fields · synced Jun 18, 2026