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Chemical Indicator card
EUDAMEDClass I (EU MDR)
Ref Hydrogen Peroxide Low-Temperature Plasma Sterilization Chemical Indicator CardModel Hydrogen Peroxide Low-Temperature Plasma Sterilization Chemical Indicator Card, Steam Sterilization Chemical Indicator CardRef Steam Sterilization Chemical Indicator Card
Identity
- Device Name
- Chemical Indicator card EUDAMED
- Model / Reference
- Hydrogen Peroxide Low-Temperature Plasma Sterilization Chemical Indicator Card, Steam Sterilization Chemical Indicator Card EUDAMEDHydrogen Peroxide Low-Temperature Plasma Sterilization Chemical Indicator Card EUDAMEDSteam Sterilization Chemical Indicator Card EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971085850115 EUDAMED06971085850122 EUDAMED
- Basic UDI-DI
- 697108585INDICATORCARDP9 EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER 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
Category: Sterilizer/disinfector rack
Chemical Indicator card by Hebei Ruihan Medical Equipment Technology 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 | 697108585INDICATORCARDP9 | 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 7dc08bbc-c4b3-4024-8d7a-749090a2c001 61 fields · synced Jul 15, 2026
- EUDAMED ede9c246-5b49-4aa3-96ec-dcd58666ae2e 61 fields · synced May 18, 2026