DENTAPEN Finger grips spix
EUDAMEDFDA UDIClass I (EU MDR)
by Juvaplus SA
Identity
- Trade Name
- DENTAPEN Finger grips spix EUDAMEDDentapen Finger Grip for Nerve Block FDA UDI
- Generic Name
- Dental anaesthesia syringe, reusable FDA UDI
- Device Name
- Finger grips spix EUDAMEDGrips that facilitate certain injections, such as Spine Spix FDA UDI
- Model / Reference
- Dentapen EUDAMEDDP04 EUDAMEDFinger Grip for Nerve Block for Dentapen FDA UDI
- Description
- Grips that facilitate certain injections, such as Spine Spix FDA UDI
Identifiers
- Catalog Number
- DP04 FDA UDI
- Primary DI / UDI-DI
- *+EJUVDP041/$$7XXXXXXZ* EUDAMEDEJUVDP047 FDA UDI
- Basic UDI-DI
- ++EJUVDP04CC 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
Yes
Category: Device sterilization/disinfection container, reusable
DENTAPEN Finger grips spix 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
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EJUVDP04CC | 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 74579b0e-7994-451c-83bb-53cac1dd6e71 61 fields · synced Jun 19, 2026
- FDA UDI 9e2cf8ce-cd86-4eee-9366-5c0f2e527ea4 35 fields · synced May 30, 2026