Identity
- Trade Name
- Mischkanülen EUDAMEDMixing tips FDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- Mischkanülen EUDAMEDMixing tips type 11 FDA UDIMixing tips type 12 FDA UDI
- Model / Reference
- 2192 EUDAMEDFDA UDI2191 EUDAMEDFDA UDI
- Description
- Mixing tips type 11 FDA UDIMixing tips type 12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- E22121921 EUDAMEDFDA UDIE22121911 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210140060000000AL EUDAMED
- FDA Product Code
- EID FDA UDI
- EMDN Code
- Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMED
- GMDN Term
- Dental material mixing nozzle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material mixing nozzle
Mischkanülen by VOCO GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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
- #1031-EU — Kuraray Noritake Dental Inc. Kurashiki · Class I
- Plasdent — PLASDENT CORP. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E2210140060000000AL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (4)
- EUDAMED 05c259fc-1018-47cb-ba64-54d80e3bfeb3 61 fields · synced Oct 6, 2026
- FDA UDI 0572e381-304b-4e85-8fd0-38cac8bb7bda 34 fields · synced May 30, 2026
- FDA UDI 82d20057-c110-413b-b480-361bba8e0d94 34 fields · synced May 30, 2026
- EUDAMED 5bfe3a48-2e42-4f42-b1c4-ada5a9258c5d 61 fields · synced Jul 19, 2026