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Irrigation Needle
EUDAMEDClass I (EU MDR)
Ref TINE.27.25.2HModel TiaEndo Irrigation Needles: TIN.27.25.2H, TIN.30.25.2HTiaEndo Irrigation Needles Elite: TINE.27.25.2H, TINE.30.25.2H, TINE.27.25.1H, TINE.30.25.1H, TIN.27.25.1H, TIN.30.25.1H
by TiaDent Inc
Identity
- Device Name
- Irrigation Needle EUDAMED
- Model / Reference
- TiaEndo Irrigation Needles: TIN.27.25.2H, TIN.30.25.2HTiaEndo Irrigation Needles Elite: TINE.27.25.2H, TINE.30.25.2H, TINE.27.25.1H, TINE.30.25.1H, TIN.27.25.1H, TIN.30.25.1H EUDAMEDTINE.27.25.2H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810190260241 EUDAMED
- Basic UDI-DI
- 081019026TINBW EUDAMED
- EMDN Code
- A010602 DENTAL IRRIGATION NEEDLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Irrigation Needle by TiaDent Inc — 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 | 081019026TINBW | Class I | Active |
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Manufacturer
- Manufacturer
- TiaDent Inc
- EUDAMED SRN
- US-MF-000049704
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ad4d71a8-3fe1-4913-88a6-b83a7734709c 61 fields · synced Jun 19, 2026