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Sterilization Packing Material (Roll）
EUDAMEDClass I (EU MDR)
Ref N/AModel Flat Reel Flat Pouch Gusseted Reel Gusseted Pouch
Identity
- Device Name
- Sterilization Packing Material (Roll） EUDAMED
- Model / Reference
- Flat Reel Flat Pouch Gusseted Reel Gusseted Pouch EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944270105017 EUDAMED
- Basic UDI-DI
- 69442701YB01R8 EUDAMED
- EMDN Code
- S01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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 Packing Material (Roll） by Jiangmen New Era External Use Drug 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 | 69442701YB01R8 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangmen New Era External Use Drug Co., Ltd
- EUDAMED SRN
- CN-MF-000036495
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9dc0deed-ffdf-4a72-8036-a34c47e027e7 61 fields · synced Jun 19, 2026