Sterile transparent drape with adhesive

EUDAMEDFDA UDI

Class I (EU MDR)

Ref HY1-05902Model Sterile Surgical Drapes

by Hygitech

Identity

Trade Name: Sterile transparent drape with adhesive EUDAMED
HYGITECH FDA UDI
Generic Name: Surgical drape adhesive FDA UDI
Device Name: Sterile transparent drape with adhesive HYGITECH Reference: HY-05902 Practical for all surgeries, the transparent sterile drape with adhesive allows the protection of the implantology motor or the control unit without compromising the sterility of the surgery. The transparency ensures you can keep an eye on the indications shown on the screen and easily change the programme. More info Characteristics : • 1 waterproof layer of polyethylene (65g/m²) • Dimensions: 40 (width) cm x 50 (length) cm • Adhesive: Located along the width of the drape(40 x 5 cm) Waterproof protection of surfaces -Effective barrier to fight against cross contaminations in non autoclavable elements. - Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer Solidity - Resistant, does not tear FDA UDI
Model / Reference: Sterile Surgical Drapes EUDAMED
HY1-05902 EUDAMED
HY-05902 FDA UDI
Description: Sterile transparent drape with adhesive HYGITECH Reference: HY-05902 Practical for all surgeries, the transparent sterile drape with adhesive allows the protection of the implantology motor or the control unit without compromising the sterility of the surgery. The transparency ensures you can keep an eye on the indications shown on the screen and easily change the programme. More info Characteristics : • 1 waterproof layer of polyethylene (65g/m²) • Dimensions: 40 (width) cm x 50 (length) cm • Adhesive: Located along the width of the drape(40 x 5 cm) Waterproof protection of surfaces -Effective barrier to fight against cross contaminations in non autoclavable elements. - Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer Solidity - Resistant, does not tear FDA UDI

Identifiers

Catalog Number: HY-05902 FDA UDI
Primary DI / UDI-DI: 03615140003865 EUDAMEDFDA UDI
Basic UDI-DI: 361514H2PREN122V9 EUDAMED
FDA Product Code: KKX FDA UDI
EMDN Code: T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
GMDN Term: Surgical drape adhesive FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 878.4370 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterile transparent drape with adhesive by Hygitech — Class I — 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	361514H2PREN122V9	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Hygitech
EUDAMED SRN: FR-MF-000007549

Sources (2)

EUDAMED 43973715-bb6d-4f63-b2a7-f71bcc274212 61 fields · synced Jul 17, 2026
FDA UDI 00603291-5546-4da1-a990-34bcfb7d85f2 34 fields · synced May 30, 2026