Identity
- Trade Name
- EKpDH-0,1-01-"ELAT" EUDAMED
- Device Name
- EKa(p)DH EUDAMED
- Model / Reference
- 1014908 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04602122000645 EUDAMED
- Basic UDI-DI
- 4602122004988PD EUDAMED
- Direct Marketing DI
- 04602122000645 EUDAMED
- EMDN Code
- Z12011399 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
EKpDH-0, 1-01-"ELAT" by Yelatma Instrument-Making Enterprise Joint-Stock Company — 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 | 4602122004988PD | Class I | Active |
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Manufacturer
- EUDAMED SRN
- RU-MF-000008411
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED b6eef87a-b26e-4d9f-9bff-19456d79b4cd 61 fields · synced Oct 5, 2026