Identity
- Trade Name
- Bio Apply-Tips regular EUDAMED
- Device Name
- Applikationsstäbchen, dental EUDAMED
- Model / Reference
- 003300 EUDAMED640052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099637006079 EUDAMED
- Basic UDI-DI
- 409963700330042 EUDAMED
- Unit of Use DI
- 04099637006062 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 regular by Hager & Werken GmbH & Co. KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental material injection cannula, single-use.
- Clinician's Choice® Needle Tubes & Plugs — Den-Mat Holdings, LLC · Class I
- PRIME|ONE — Akzenta International SA · Class I
- NaviTip Tips — ULTRADENT PRODUCTS, INC. · Class I
- CanalPro™ Color Syringes — Coltène/Whaledent AG · Class I
- RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
- Avalon Biomed NeoSEALER 20 Flex Flo Tips — NUSMILE, LTD · Class I
- EDS Mixing Tips — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- PRIME|ONE — Akzenta International SA · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hager & Werken GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000004938
Sources (1)
- EUDAMED 6280c275-f332-4adf-ac47-87de33fea888 61 fields · synced Jun 19, 2026