Identity
- Model / Reference
- Mixing tips EUDAMED#4221-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110802218 EUDAMED
- Basic UDI-DI
- 458211076MixingtipQT EUDAMED
- EMDN Code
- Q010506 PASTE APPLICATORS, 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 mixing nozzle
#4221-Eu by Kuraray Noritake Dental Inc. Kurashiki — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental material mixing nozzle.
- Adhesive Tip Applicator — Huanghua Promisee Dental Co.Ltd. · Class I
- 3.2 Mixing Tips with Integrated Needle 25-Pack — Den-Mat Holdings, LLC · Class I
- RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Imprint™ 4 Regular — 3M Deutschland GmbH · Class II
- Cling2®/Temptation® Now 1:1 Mixing Tips — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Protemp™ Plus — 3M Deutschland GmbH · 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 | 458211076MixingtipQT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kuraray Noritake Dental Inc. Kurashiki
- EUDAMED SRN
- JP-MF-000017326
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED f5065d86-604e-45da-a149-79d88a922ab5 61 fields · synced Jul 16, 2026