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Vaporized Hydrogen Peroxide Indicator Tape
EUDAMEDClass I (EU MDR)
Ref M311Model M311 Ref N/A
Identity
- Device Name
- Vaporized Hydrogen Peroxide Indicator Tape EUDAMED
- Model / Reference
- M311 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944270105109 EUDAMED06944270105048 EUDAMED
- Basic UDI-DI
- 69442701M311LH EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDNetherlands 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
Category: Sterilizer/disinfector rack
Vaporized Hydrogen Peroxide Indicator Tape by Jiangmen New Era External Use Drug Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69442701M311LH | 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 (2)
- EUDAMED 2aa355c6-c6ec-4d32-a080-a111dbcd39e6 61 fields · synced Aug 4, 2026
- EUDAMED bf46d505-6c7e-4a20-887e-6f057db57881 61 fields · synced Aug 4, 2026