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Chemical Indicator Tape
EUDAMEDClass I (EU MDR)
Ref FM101Model ST101 ST104 HP103 HP104 EO101 FM101Ref EO101Ref ST104Ref HP104Ref HP103
Identity
- Device Name
- Chemical Indicator Tape EUDAMED
- Model / Reference
- ST101 ST104 HP103 HP104 EO101 FM101 EUDAMEDFM101 EUDAMEDEO101 EUDAMEDST104 EUDAMEDHP104 EUDAMEDHP103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978563510127 EUDAMED06978563510110 EUDAMED06978563510073 EUDAMED06978563510103 EUDAMED06978563510097 EUDAMED
- Basic UDI-DI
- 697856351CIT01NR EUDAMED
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (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
Chemical Indicator Tape by Nantong Ineuthink Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697856351CIT01NR | Class I | Active |
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Manufacturer
- Manufacturer
- Nantong Ineuthink Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000047513
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 6896824c-3540-46bf-92d8-aabcec8e7821 61 fields · synced Oct 6, 2026
- EUDAMED 7740965a-f5f6-4b4a-984f-a1a86fca4575 61 fields · synced May 17, 2026
- EUDAMED ad91b933-f387-4418-a60e-a41d4eec2ef1 61 fields · synced May 17, 2026
- EUDAMED d4a35cf5-cbdc-4fa1-a1f2-8208e04fc45e 61 fields · synced May 18, 2026
- EUDAMED ded2b92c-c19e-4513-9386-95a3d6b5e417 61 fields · synced May 19, 2026