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Sterilization Packing Material (Roll）
EUDAMEDClass I (EU MDR)
Ref Flat ReelModel 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 EUDAMEDFlat Reel EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944270105000 EUDAMED
- Basic UDI-DI
- 69442701YB01R8 EUDAMED
- EMDN Code
- S01020101,S01020102,S01020201,S01020301,S010299 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 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 6dcdb2d6-0665-484f-8fde-b0b110d4c2d9 61 fields · synced Jun 19, 2026