Identity
- Trade Name
- BELLIGER ACE EUDAMED
- Device Name
- BELLIGER ACE (AREX) EUDAMED
- Model / Reference
- A03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809244060557 EUDAMED08809244060533 EUDAMED
- Basic UDI-DI
- 880924406AREXKQ EUDAMED
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Belliger Ace (arex) by Genoray Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252229 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880924406AREXKQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- GENORAY CO., Ltd.
- EUDAMED SRN
- KR-MF-000021014
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 8f9941bb-b821-4e8e-ac3a-4b533b72bdc0 85 fields · synced Aug 1, 2026
- EUDAMED bc16275a-6bcd-4093-b739-9b342d01f848 61 fields · synced May 18, 2026
- FDA 510(k) K252229 1 fields · synced May 18, 2026