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Sterilization Chemical Indicator Strip
EUDAMEDClass I (EU MDR)
Ref Type 5 20mm*140mmModel Type 1, Type 2, Type 4, Type 5, Type 6 Ref Type 2 5mm*75mm
Identity
- Device Name
- Sterilization Chemical Indicator Strip EUDAMED
- Model / Reference
- Type 1, Type 2, Type 4, Type 5, Type 6 EUDAMEDType 5 20mm*140mm EUDAMEDType 2 5mm*75mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978194940225 EUDAMED06978194940195 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
- France 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
Sterilization Chemical Indicator Strip by Tianjin Li Feng Industry and Trade Development Co., Ltd. — Class I — MDR — listed in EUDAMED
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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 | 697819494SCIS01Z3 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000045898
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED abc78912-c596-4749-8221-95635480d4f0 61 fields · synced Jul 19, 2026
- EUDAMED cbf258d9-0bac-4ccc-bd4a-fd5615f2b2ea 61 fields · synced May 18, 2026