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Sterilized packaging bag
EUDAMEDClass I (EU MDR)
Ref Disposable Sterilization PouchModel Hydrogen Peroxide Low-Temperature Plasma Sterilization Pouch, Disposable Sterilization PouchRef Hydrogen Peroxide Low-Temperature Plasma Sterilization Pouch
Identity
- Device Name
- Sterilized packaging bag EUDAMED
- Model / Reference
- Hydrogen Peroxide Low-Temperature Plasma Sterilization Pouch, Disposable Sterilization Pouch EUDAMEDDisposable Sterilization Pouch EUDAMEDHydrogen Peroxide Low-Temperature Plasma Sterilization Pouch EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971085850092 EUDAMED06971085850085 EUDAMED
- Basic UDI-DI
- 697108585PACKAGINGBAG6C EUDAMED
- EMDN Code
- S01020102 STERILISATION REELS, GUSSETED, PAPER/PLASTIC FILM EUDAMEDS01020101 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
Sterilized packaging bag by Hebei Ruihan Medical Equipment Technology 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 | 697108585PACKAGINGBAG6C | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Ruihan Medical Equipment Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000048839
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 81fe835f-e9b0-4871-bc4b-eb05797b1c7c 61 fields · synced Jul 16, 2026
- EUDAMED cca00ca6-7886-41bd-a6f1-c11de6c348da 61 fields · synced May 18, 2026