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Speed Gun
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8181Model Dental material applicators
Identity
- Trade Name
- SPEED GUN EUDAMEDFDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, single-component FDA UDI
- Device Name
- SPEED GUN EUDAMEDSystem for application of dental materials. FDA UDI
- Model / Reference
- Dental material applicators EUDAMED8181 EUDAMEDSPEED GUN 1 unit FDA UDI
- Description
- System for application of dental materials. FDA UDI
Identifiers
- Catalog Number
- 8181 FDA UDI
- Primary DI / UDI-DI
- 07898078650134 EUDAMEDFDA UDI
- Basic UDI-DI
- 807865CONSERVATIVESGG EUDAMED
- FDA Product Code
- EKI 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
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
Yes
FDA UDI
Speed Gun by Angelus Indústria De Produtos Odontológicos S/A — 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 | 807865CONSERVATIVESGG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Angelus Indústria De Produtos Odontológicos S/A
- EUDAMED SRN
- BR-MF-000010255
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4eaaf988-6444-48e4-9c52-f8c5e3df2797 61 fields · synced Jul 9, 2026
- FDA UDI fa801089-440c-4df5-9d5a-c709b99d698c 35 fields · synced May 30, 2026