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Chemical Indicator Tape
EUDAMEDClass I (EU MDR)
Ref High-Temperature Autoclave Sterilization Indicator TapeModel High-Temperature Autoclave Sterilization Indicator Tape, Low-Temperature Plasma Sterilization Chemical Indicator Tape
Identity
- Device Name
- Chemical Indicator Tape EUDAMED
- Model / Reference
- High-Temperature Autoclave Sterilization Indicator Tape, Low-Temperature Plasma Sterilization Chemical Indicator Tape EUDAMEDHigh-Temperature Autoclave Sterilization Indicator Tape EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971085850139 EUDAMED
- Basic UDI-DI
- 697108585INDICATORTAPESU 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 Tape 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 | 697108585INDICATORTAPESU | 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 (1)
- EUDAMED 6086982b-00e7-4944-9275-1fded80aec27 61 fields · synced Jul 31, 2026