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STERIKING® LT-Blueline Heat-Sealable Rolls
EUDAMEDClass I (EU MDR)
Ref LTR45Ref LTR42Ref LTR49Ref LTR44Ref LTR43Ref LTR41
Identity
- Trade Name
- STERIKING® LT-Blueline Heat-Sealable Rolls EUDAMED
- Device Name
- STERIKING® Pouches and Rolls EUDAMED
- Model / Reference
- LTR45 EUDAMEDLTR42 EUDAMEDLTR49 EUDAMEDLTR44 EUDAMEDLTR43 EUDAMEDLTR41 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974610341195 EUDAMED06974610341157 EUDAMED06974610341225 EUDAMED06974610341188 EUDAMED06974610341164 EUDAMED06974610341133 EUDAMED
- Basic UDI-DI
- 697461034ST16010HM EUDAMED
- EMDN Code
- S01020201 FLAT STERILISATION REELS, 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 Rolls 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 (6)
- EUDAMED 4b86e65a-579b-44c8-a2db-c7ca39946a71 61 fields · synced Sep 18, 2026
- EUDAMED 6e831093-c422-46e6-a1e0-a9a7d0c9acb9 61 fields · synced May 19, 2026
- EUDAMED 6849b705-9d2b-41e3-a3c2-934b03283731 61 fields · synced May 19, 2026
- EUDAMED 12f76288-971b-4ace-85bd-b28eb824b563 61 fields · synced May 19, 2026
- EUDAMED 46dae547-c760-48fa-b0bb-31961ec76b50 61 fields · synced May 19, 2026
- EUDAMED 3bff3f06-6d1b-4c6d-a502-f5e360bf45ed 61 fields · synced May 19, 2026