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Natural Latex Rubber Condoms

EUDAMED

Class IIb (EU MDR)

Ref Width:49±2mm(Classic )Model Classic;Dotted; Dotted & Ribbed & Classic; Ultrathin Classic; Ribbed; Classic without seminal vesicle);Flavored, Colored

by Shandong Ming Yuan Latex Co., Ltd.

Identity

Device Name
Natural Latex Rubber Condoms EUDAMED
Model / Reference
Classic;Dotted; Dotted & Ribbed & Classic; Ultrathin Classic; Ribbed; Classic without seminal vesicle);Flavored, Colored EUDAMED
Width:49±2mm(Classic ) EUDAMED

Identifiers

Primary DI / UDI-DI
06949402860017 EUDAMED
Basic UDI-DI
694940280001J4 EUDAMED
Direct Marketing DI
06949402860017 EUDAMED
EMDN Code
U110101 CONDOMS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Lithuania EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

Yes

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

Natural Latex Rubber Condoms by Shandong Ming Yuan Latex Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000045347
Authorised Representative
BioDomi GmbH DE-AR-000016611

Sources (1)

  • EUDAMED 1e88a441-97d3-40e0-8a86-c1974e36adbb 61 fields · synced Jun 20, 2026