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STERIKING® LT-Blueline Self-Sealable Pouches
EUDAMEDClass I (EU MDR)
Ref LTSS4Ref LTSS5A
Identity
- Trade Name
- STERIKING® LT-Blueline Self-Sealable Pouches EUDAMED
- Device Name
- STERIKING® Pouches and Rolls EUDAMED
- Model / Reference
- LTSS4 EUDAMEDLTSS5A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974610340402 EUDAMED06974610340396 EUDAMED
- Basic UDI-DI
- 697461034ST16010HM EUDAMED
- EMDN Code
- S01010201 FLAT STERILISATION POUCHES, TYVEK/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® LT-Blueline Self-Sealable Pouches by Wipak Packaging (Changshu) co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Wipak Packaging (Changshu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009613
- Authorised Representative
- Wipak Oy FI-AR-000009165
Sources (2)
- EUDAMED fe4bb851-5b52-4e41-8db8-a26fe5440163 61 fields · synced Jul 20, 2026
- EUDAMED 8f2191ab-b8d9-4c04-ad7b-c4ae935e43ea 61 fields · synced May 19, 2026