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Sterilization Rolls & Pouches
EUDAMEDClass I (EU MDR)
Ref 57x100mmModel 57x100mm,57x130mm,70x260mm, 90x165mm, 90x260mm,135x260mm, 135x280mm,155x260mm,190x360mm, 230x395mm,300x395mm, 305x430mm, 50mmx200m,100mmx200m,150mmx200m, 200mm*200m,250m*200m,300mm*200m, 350mm*200m,400mm*200m
Identity
- Device Name
- Sterilization Rolls & Pouches EUDAMED
- Model / Reference
- 57x100mm,57x130mm,70x260mm, 90x165mm, 90x260mm,135x260mm, 135x280mm,155x260mm,190x360mm, 230x395mm,300x395mm, 305x430mm, 50mmx200m,100mmx200m,150mmx200m, 200mm*200m,250m*200m,300mm*200m, 350mm*200m,400mm*200m EUDAMED57x100mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975336240588 EUDAMED
- Basic UDI-DI
- 697533624RSP009R7 EUDAMED
- EMDN Code
- S01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Sterilization Rolls & Pouches by Rocodent International Limited — 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 | 697533624RSP009R7 | Class I | Active |
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Manufacturer
- Manufacturer
- Rocodent International Limited
- EUDAMED SRN
- CN-MF-000045441
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 73df3faf-9760-4823-8679-51d0a4258564 61 fields · synced Jun 18, 2026