Dentapen finger grips
EUDAMEDFDA UDIClass I (EU MDR)
by Juvaplus SA
Identity
- Trade Name
- Dentapen finger grips EUDAMEDDentapen Finger Grip FDA UDI
- Generic Name
- Dental anaesthesia syringe, reusable FDA UDI
- Device Name
- Finger grips EUDAMEDGrip that mimic the standard mechanical Anaesthasia syringe ergonomics FDA UDI
- Model / Reference
- Dentapen EUDAMEDDP02 EUDAMEDFinger Grip for Dentapen FDA UDI
- Description
- Grip that mimic the standard mechanical Anaesthasia syringe ergonomics FDA UDI
Identifiers
- Catalog Number
- DP02 FDA UDI
- Primary DI / UDI-DI
- *+EJUVDP021/$$7XXXXXXZ* EUDAMEDEJUVDP027 FDA UDI
- Basic UDI-DI
- ++EJUVDP02C8 EUDAMED
- FDA Product Code
- EJI FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Dental anaesthesia syringe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6770 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Dentapen finger grips by Juvaplus Sa — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EJUVDP02C8 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++EJUVDP02C8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Juvaplus SA
- EUDAMED SRN
- CH-MF-000017503
- Authorised Representative
- EUSwissMed GmbH DE-AR-000016945
Sources (2)
- EUDAMED 8f7b8cbb-f441-4731-bad3-53fd5dfc36a5 61 fields · synced Jun 8, 2026
- FDA UDI f91a4bb7-3130-44c4-b95f-73bcd44a94e7 35 fields · synced May 29, 2026