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Sterilization Chemical Indicator Strip
EUDAMEDClass I (EU MDR)
Ref Type 1 40mm*70mmModel Type 1, Type 2, Type 4, Type 5, Type 6
Identity
- Device Name
- Sterilization Chemical Indicator Strip EUDAMED
- Model / Reference
- Type 1, Type 2, Type 4, Type 5, Type 6 EUDAMEDType 1 40mm*70mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978194940188 EUDAMED
- Basic UDI-DI
- 697819494SCIS01Z3 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
Sterilization Chemical Indicator Strip by Tianjin Li Feng Industry and Trade Development Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 697819494SCIS01Z3 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000045898
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED dba79aa2-b39b-4011-8810-4e3a15840d60 61 fields · synced Jun 19, 2026