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Surgery needle N°1 L

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 20228

by Produits Dentaires SA

Identity

Trade Name
Surgery needle N°1 L EUDAMED
SURGERY NEEDLE LEFT N.0 RED FDA UDI
Generic Name
Dental amalgam carrier FDA UDI
Device Name
MAP System - Intro Kit EUDAMED
N°1/L Red diam Ø 1.10 mm 8 POM plungers 1 NiTi cleaning curette FDA UDI
Model / Reference
20228 EUDAMEDFDA UDI
Description
N°1/L Red diam Ø 1.10 mm 8 POM plungers 1 NiTi cleaning curette FDA UDI

Identifiers

Primary DI / UDI-DI
07640159160403 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 EUDAMED
Class 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Surgery needle N°1 L 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

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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 434db5fc-4e66-4bdf-bd3e-cc77963bad35 61 fields · synced Jun 18, 2026
  • FDA UDI 1053288f-7d27-46a8-a3ee-816424c7b79f 34 fields · synced May 29, 2026