Identity
- Trade Name
- Bio Apply-Tips super-fine EUDAMED
- Device Name
- Applikationsstäbchen, dental EUDAMED
- Model / Reference
- 003300 EUDAMED640050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099637006031 EUDAMED
- Basic UDI-DI
- 409963700330042 EUDAMED
- Unit of Use DI
- 04099637006024 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE 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
Category: Dental material injection cannula, single-use
Bio Apply-Tips super-fine by Hager & Werken GmbH & Co. KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental material injection cannula, single-use.
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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 | 409963700330042 | Class I | Active |
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Manufacturer
- Manufacturer
- Hager & Werken GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000004938
Sources (1)
- EUDAMED c20eadd6-ac7b-4cbe-a49c-e289b44fb62d 61 fields · synced Aug 3, 2026