Identity
- Trade Name
- Chemdye™ KHP2X15-7.0Y/250CH EUDAMED
- Device Name
- Terragene® Cleaning, disinfection and sterilization indicators EUDAMED
- Model / Reference
- KHP2X15-7.0Y/250CH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798375774048 EUDAMED
- Basic UDI-DI
- 779816467CI5L EUDAMED
- EMDN Code
- S9080 DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Chemdye™ KHP2X15-7.0Y/250CH by Terragene S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 779816467CI5L | Class I | Active |
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Manufacturer
- Manufacturer
- Terragene S.A.
- EUDAMED SRN
- AR-MF-000047833
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED bc4e1dba-8548-406b-b362-dada1d720a9a 61 fields · synced Aug 1, 2026