← Back to catalogue
STERIKING® See-Through Heat-Sealable Rolls
EUDAMEDClass I (EU MDR)
Ref R39/31; R39-3P/31
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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697461034ST16010HM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wipak Packaging (Changshu) Co., Ltd.
- 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