Identity
- Trade Name
- Single Tim FDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- Single Tim EUDAMED
- Model / Reference
- 2247 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- E22122471 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E22101401000000007R EUDAMED
- FDA Product Code
- FRL FDA UDI
- EMDN Code
- Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMED
- GMDN Term
- Dental material application tool, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5300 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
Single Tim by VOCO GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | ++E22101401000000007R | 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 (2)
- EUDAMED 25a52480-9b54-4140-b950-403e6aa0b052 61 fields · synced Jul 16, 2026
- FDA UDI a50985ee-a4c8-4b91-95c7-4d176aad745b 33 fields · synced May 30, 2026