Identity
- Device Name
- Dental Tray 190x100x25 mm EUDAMED
- Model / Reference
- HR-2970 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HR-2970LS EUDAMED
- Basic UDI-DI
- B-HR-2970LS EUDAMED
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental Tray 190x100x25 mm by Hossa International — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-HR-2970LS | Class I | Active |
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Manufacturer
- Manufacturer
- Hossa International
- EUDAMED SRN
- PK-MF-000039276
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 8ee7297e-f828-4799-9290-114d7a830691 61 fields · synced Jul 24, 2026