Identity
- Trade Name
- Compule Gun Light Grey Unodent EUDAMEDAstek FDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, single-component FDA UDI
- Device Name
- Compule Gun Light Grey Unodent EUDAMEDCompule Gun - Light Grey - Unodent FDA UDI
- Model / Reference
- 11650UNODENT EUDAMEDFDA UDI
- Description
- Compule Gun - Light Grey - Unodent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840326423783 EUDAMEDFDA UDI
- Basic UDI-DI
- 50601117835696FP EUDAMED
- FDA Product Code
- EID FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material cartridge-plunging applicator, single-component 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Compule Gun Light Grey Unodent by Astek Innovations Ltd — 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 | 50601117835696FP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Astek Innovations Ltd
- EUDAMED SRN
- GB-MF-000013346
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED 29d41ab7-6caf-4487-9adc-2f9469a8dff0 61 fields · synced Jul 11, 2026
- FDA UDI 4812c364-f27c-4f28-a949-a4e7c3e8196b 34 fields · synced May 30, 2026