Identity
- Device Name
- Chemical Indicator Strip EUDAMED
- Model / Reference
- S010399 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975803830410 EUDAMED
- Basic UDI-DI
- 697580383HCCIS0035K EUDAMED
- EMDN Code
- S010399 MATERIALS FOR PACKAGING PACKS TO BE STERILIZED - 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 Strip by Hefei Hanchin Medical Supplies 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 | 697580383HCCIS0035K | Class I | Active |
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Manufacturer
- Manufacturer
- Hefei Hanchin Medical Supplies Co., Ltd
- EUDAMED SRN
- CN-MF-000030468
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 3e446849-c430-4530-8cef-3544ebaeb2f6 61 fields · synced Jul 8, 2026