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STERIKING® See-Through Heat-Sealable Rolls

EUDAMED

Class I (EU MDR)

Ref R39/31; R39-3P/31

by Wipak Packaging (Changshu) Co., Ltd.

Identity

Trade Name
STERIKING® See-Through Heat-Sealable Rolls EUDAMED
Device Name
STERIKING® Pouches and Rolls EUDAMED
Model / Reference
R39/31; R39-3P/31 EUDAMED

Identifiers

Primary DI / UDI-DI
06974610340150 EUDAMED
Basic UDI-DI
697461034ST16010HM EUDAMED
EMDN Code
S01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Finland EUDAMED

Clinical & Handling

Sterile

No

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

Steriking Pouches and Rolls are a type of heat-sealable roll that provides a sterile environment for various medical applications. These rolls are designed to be used in clinical settings, such as operating rooms or intensive care units, where maintaining sterility is crucial.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000009613
Authorised Representative
Wipak Oy FI-AR-000009165

Sources (2)

  • EUDAMED 769b1830-91ca-4ea1-894c-fe6f9649ba48 61 fields · synced Oct 6, 2026
  • EUDAMED 769b1830-91ca-4ea1-894c-fe6f9649ba48-1 61 fields · synced Jun 9, 2026