Identity
- Device Name
- Indicator Tape EUDAMED
- Model / Reference
- S010399 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975803830687 EUDAMED
- Basic UDI-DI
- 697580383HC0IT005WH 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
Indicator Tape 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 | 697580383HC0IT005WH | 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 26dcdd54-0fde-486a-bff2-6b7c22149fc2 61 fields · synced Jun 19, 2026