Identity
- Trade Name
- Syringe MAP System EUDAMEDMAP SYSTEM MAP SYRINGE FDA UDI
- Generic Name
- Dental amalgam carrier FDA UDI
- Device Name
- MAP System - Intro Kit EUDAMED1 Sterilisable aluminium case 185x95x30 mm 1 Stainless steel syringe 1 NiTi memory shape needle N°1 Red + N°0 Yellow + N°2 Blue 8 Spare POM plungers N°1 Red + N°0 Yellow + N°2 Blue 1 NiTi cleaning curette N°1 Red + N°0 Yellow + N°2 Blue 1 paste cleaning device stops N°1 Red + N°0 Yellow + N°2 Blue 1 NiTi memory shape needle N°1 Red + N°0 Yellow + N°2 Blue 1 Stainless steel well diam 14mm FDA UDI
- Model / Reference
- 20242 EUDAMED20285 FDA UDI
- Description
- 1 Sterilisable aluminium case 185x95x30 mm 1 Stainless steel syringe 1 NiTi memory shape needle N°1 Red + N°0 Yellow + N°2 Blue 8 Spare POM plungers N°1 Red + N°0 Yellow + N°2 Blue 1 NiTi cleaning curette N°1 Red + N°0 Yellow + N°2 Blue 1 paste cleaning device stops N°1 Red + N°0 Yellow + N°2 Blue 1 NiTi memory shape needle N°1 Red + N°0 Yellow + N°2 Blue 1 Stainless steel well diam 14mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159160045 EUDAMEDFDA UDI
- Basic UDI-DI
- 764015916MAPSYSTEMYA EUDAMED
- FDA Product Code
- EKI FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental amalgam carrier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Syringe MAP System by Produits Dentaires SA — Class IIa — 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 | 764015916MAPSYSTEMYA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-MF-000023147
- Authorised Representative
- PD DENTAL EU SAS FR-AR-000017144
Sources (2)
- EUDAMED cbdc59e8-278a-4dfa-8e00-96908bbde80c 61 fields · synced Jun 20, 2026
- FDA UDI fbe1083c-ff39-4d65-87d3-6a3cc23fe403 34 fields · synced May 30, 2026