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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Isolation Gown XL — Class I MDR by HYGITECH

MD Atlas
HYGITECH

EUDAMED last updated this device on Jan 15, 2026

Isolation Gown XL

361514H2PRIN112WJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HYGITECH
UDI-DI code: 03615140006606
Reference / catalog number: HY1-50044

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Manufacturer information

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

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Critical warnings

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

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

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: Isolation Gown XL
UDI-DI code: 03615140006606
Basic UDI-DI: 361514H2PRIN112WJ
Reference / catalog number: HY1-50044
Issuing entity: GS1

Classification

Risk category: Class I
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)

T020401STANDARD SURGICAL GOWNS

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

Certificates

Certificate health across this manufacturer's portfolio.

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