Set D'irrigation Pour M-M Intrasurge

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref HY1-110018Model Irrigation System

by Hygitech

Identity

Trade Name: SET D'IRRIGATION POUR M-M INTRASURGE EUDAMED
HYGITECH FDA UDI
Generic Name: Oral lavage system FDA UDI
Device Name: HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer FDA UDI
Model / Reference: Irrigation System EUDAMED
HY1-110018 EUDAMED
HY-110018 FDA UDI
Description: HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer FDA UDI

Identifiers

Catalog Number: HY-110018 FDA UDI
Primary DI / UDI-DI: 03615140001649 EUDAMEDFDA UDI
Basic UDI-DI: 361514H3IRRI171VW EUDAMED
FDA Product Code: EFS FDA UDI
EMDN Code: A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
GMDN Term: Oral lavage system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 872.6510 FDA UDI
Market of Registration: France EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Set D'irrigation Pour M-M Intrasurge by Hygitech — 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	361514H3IRRI171VW	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Hygitech
EUDAMED SRN: FR-MF-000007549

Sources (2)

EUDAMED 4bf04107-fec0-4338-9505-6617d357e9f9 61 fields · synced Jul 9, 2026
FDA UDI e4fb4f79-cdde-40b0-8cd4-13d98d1350e8 34 fields · synced May 26, 2026