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Organization name
UDI-DI code
Reference / catalog number

STERILE IRRIGATION SYSTEMS M-M… — Class IIa MDR by HYGITECH

MD Atlas
HYGITECH

EUDAMED last updated this device on Jan 29, 2026

STERILE IRRIGATION SYSTEMS M-M ATR HYG

361514H3IRRI171VW

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HYGITECH
UDI-DI code: 03615140003988
Reference / catalog number: HY-110003

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Manufacturer information

Organization name: HYGITECH
SRN: FR-MF-000007549
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: STERILE IRRIGATION SYSTEMS M-M ATR HYG
UDI-DI code: 03615140003988
Basic UDI-DI: 361514H3IRRI171VW
Reference / catalog number: HY-110003
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A03040299IRRIGATION KITS, SINGLE-USE - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

Certificate health across this manufacturer's portfolio.

FR23/00000045Supplemented
Quality assuranceNotified body: 1639Expiry: Apr 11, 2028