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STERIKING® See-Through Gusseted Rolls
EUDAMEDFDA UDIClass I (EU MDR)
Ref RB52; RB52-3P
by Wipak Oy
Identity
- Trade Name
- STERIKING® See-Through Gusseted Rolls 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
- RB52; RB52-3P EUDAMEDRB52 FDA UDI
- Description
- Single use sterilization packaging FDA UDI
Identifiers
- Catalog Number
- RB52-3P FDA UDI
- Primary DI / UDI-DI
- 06438263650115 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438263ST14010NK EUDAMED
- 510(k) Number
- K953776 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S01020102 STERILISATION REELS, GUSSETED, PAPER/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® See-Through Gusseted Rolls 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 (3)
- EUDAMED 5e5c00ff-cd57-4c62-9730-290e0c613497 61 fields · synced Jul 24, 2026
- FDA UDI cff2359f-30dd-4148-87fc-b0efab5ccb54 35 fields · synced May 30, 2026
- EUDAMED 5e5c00ff-cd57-4c62-9730-290e0c613497-1 61 fields · synced Jun 10, 2026