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STERIKING® LT-Blueline Heat-Sealable Pouches
EUDAMEDClass I (EU MDR)
Ref LTS1025Ref LTS1660Ref LTS1644Ref LTS2550Ref LTS2538
Identity
- Trade Name
- STERIKING® LT-Blueline Heat-Sealable Pouches EUDAMED
- Device Name
- STERIKING® Pouches and Rolls EUDAMED
- Model / Reference
- LTS1025 EUDAMEDLTS1660 EUDAMEDLTS1644 EUDAMEDLTS2550 EUDAMEDLTS2538 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974610340495 EUDAMED06974610340464 EUDAMED06974610340471 EUDAMED06974610340433 EUDAMED06974610340440 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 Heat-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 (5)
- EUDAMED 837cbb9d-2b3a-4e3a-86c9-5f98b26064fd 61 fields · synced Oct 6, 2026
- EUDAMED 821e94e0-c362-4806-9d0f-728baca3d782 61 fields · synced May 16, 2026
- EUDAMED c37828b7-f9ca-46b1-9aac-edf1e3b23a34 61 fields · synced May 17, 2026
- EUDAMED 3e13a76b-aaa5-4226-939c-74f6cc6dc5ce 61 fields · synced May 17, 2026
- EUDAMED 0f5378a7-6979-41da-93b1-8013e2f74531 61 fields · synced May 18, 2026