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Sterilization Indicator Tape
EUDAMEDClass I (EU MDR)
Ref MCSTModel MCST MCET MCPTRef N/A
Identity
- Device Name
- Sterilization Indicator Tape EUDAMED
- Model / Reference
- MCST MCET MCPT EUDAMEDMCST EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975995561505 EUDAMED06975995561567 EUDAMED06975995561550 EUDAMED06975995561543 EUDAMED06975995561536 EUDAMED
- Basic UDI-DI
- 697599556SIT012F 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 Indicator Tape by Anqing MedColor Imp. & Exp. 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 | 697599556SIT012F | Class I | Active |
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Manufacturer
- Manufacturer
- Anqing MedColor Imp. & Exp. Co., Ltd
- EUDAMED SRN
- CN-MF-000032447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 5636e12c-f96d-46fd-b52e-ef0371f67a36 61 fields · synced Aug 2, 2026
- EUDAMED 75ed31c6-927a-459d-84a1-1e63a87e8d08 61 fields · synced May 17, 2026
- EUDAMED 504fb9ac-b913-4238-b341-3b89fc451bc1 61 fields · synced May 18, 2026
- EUDAMED 61152cde-7df5-468c-8a18-787c267d7c88 61 fields · synced May 19, 2026
- EUDAMED b2062ca9-33fd-4f91-9207-428a10db93fd 61 fields · synced May 19, 2026