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STERIKING® LT-Blueline Self-Sealable Pouches
EUDAMEDFDA UDIClass I (EU MDR)
Ref LTSS2
by Wipak Oy
Identity
- Trade Name
- STERIKING® LT-Blueline Self-Sealable Pouches EUDAMEDSteriking® FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- STERIKING® Pouches and Rolls EUDAMEDSingle use sterilization packaging FDA UDI
- Model / Reference
- LTSS2 EUDAMEDFDA UDI
- Description
- Single use sterilization packaging FDA UDI
Identifiers
- Catalog Number
- LTSS2 FDA UDI
- Primary DI / UDI-DI
- 06438263624024 EUDAMED06438263624093 FDA UDI
- Basic UDI-DI
- 6438263ST14010NK EUDAMED
- 510(k) Number
- K973827 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S01010201 FLAT STERILISATION POUCHES, TYVEK/PLASTIC FILM EUDAMED
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
STERIKING® LT-Blueline Self-Sealable Pouches by Wipak Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438263ST14010NK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wipak Oy
- EUDAMED SRN
- FI-MF-000004496
Sources (2)
- EUDAMED f6ff05ef-5471-4f45-a6ab-aa42f2bb4d45 61 fields · synced Jun 18, 2026
- FDA UDI 8067b8fa-de96-4f7e-b9ad-aeac5bd8a1b2 35 fields · synced May 30, 2026