Identity
- Trade Name
- Heidiemann oral spatula EUDAMED
- Device Name
- Heidiemann oral spatula EUDAMED
- Model / Reference
- ho11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003475475 EUDAMED
- Basic UDI-DI
- 08964003475HDOS115H EUDAMED
- EMDN Code
- L159013 DENTAL SPATULAS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Heidiemann oral spatula by Jazbar International — 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 | 08964003475HDOS115H | Class I | Active |
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Manufacturer
- Manufacturer
- Jazbar International
- EUDAMED SRN
- PK-MF-000031447
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 60bebbd5-0dc8-4e54-819b-2a040f9ce396 61 fields · synced Jun 18, 2026