Identity
- Trade Name
- Surgical Kit EUDAMEDMAP SYSTEM, SURGICAL KIT FDA UDI
- Generic Name
- Dental amalgam carrier FDA UDI
- Device Name
- MAP System - Intro Kit EUDAMED1 sterilisable aluminium case 185x145x30mm 1 Stainless steel syringe 1 Surgery needle N°1/R Red + N°0/R Yellow 1 Surgery needle N°1/L Red + N°0/L Yellow 1 Niti Memory shape Needle N°1 Red + N°0 Yellow 24 spare POM plungers (3x8) N°1 Red + (3x8) N°0 Yellow 1 Niti cleaning curette N°1 Red + N°0 Yellow 1 paste cleaing device stops N°1 Red + N°0 Yellow 1 Stainless steel weel diam 14mm FDA UDI
- Model / Reference
- 20287 EUDAMEDFDA UDI
- Description
- 1 sterilisable aluminium case 185x145x30mm 1 Stainless steel syringe 1 Surgery needle N°1/R Red + N°0/R Yellow 1 Surgery needle N°1/L Red + N°0/L Yellow 1 Niti Memory shape Needle N°1 Red + N°0 Yellow 24 spare POM plungers (3x8) N°1 Red + (3x8) N°0 Yellow 1 Niti cleaning curette N°1 Red + N°0 Yellow 1 paste cleaing device stops N°1 Red + N°0 Yellow 1 Stainless steel weel diam 14mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159160328 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
Surgical Kit 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 a65cb0aa-c339-447b-8440-aeadbf277b73 61 fields · synced Jun 18, 2026
- FDA UDI 76a32911-54b5-4f84-9a66-76524844ee1d 34 fields · synced May 30, 2026