Identity
- Trade Name
- Dry Incubator / EC6S-230MR EUDAMED
- Device Name
- Dry Incubator EUDAMED
- Model / Reference
- EC6S-230MR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580647510040 EUDAMED
- Basic UDI-DI
- 458064751A001IY8 EUDAMED
- Direct Marketing DI
- 04580647510040 EUDAMED
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Assisted reproduction vitrification carrier
Dry Incubator / EC6S-230MR by ASTEC CO., Ltd — Class IIa — 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 | 458064751A001IY8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ASTEC CO., Ltd
- EUDAMED SRN
- JP-MF-000020597
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 169882c4-099a-4c91-b536-53524b4dca12 61 fields · synced Jun 19, 2026