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Sterile equipment covers

EUDAMED

Class I (EU MDR)

Ref PM3502Model /

by Jiangyin PureMED Products Co., LTD

Identity

Device Name
Sterile equipment covers EUDAMED
Model / Reference
/ EUDAMED
PM3502 EUDAMED

Identifiers

Primary DI / UDI-DI
06974767553526 EUDAMED
Basic UDI-DI
69747675501E01015G EUDAMED
EMDN Code
T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED

Classification

Device Class
Class I EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Category: Vascular booties

Sterile equipment covers by Jiangyin PureMED Products Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Vascular booties.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000028858
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED 1de78027-a399-4f67-b89d-3f4cb1438814 61 fields · synced Jul 9, 2026