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uCentum
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref CS 3890-830-045Model Carrier510(k) K123717
Identity
- Trade Name
- uCentum EUDAMED
- Model / Reference
- Carrier EUDAMEDCS 3890-830-045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04052536221059 EUDAMED
- Basic UDI-DI
- 4052536000268QQ EUDAMED
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS 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
uCentum by ulrich GmbH & Co. KG — Class I — 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 | K123717 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4052536000268QQ | Class I | Active |
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Manufacturer
- Manufacturer
- ulrich GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006411
Sources (2)
- EUDAMED 6223ab9a-d868-49fd-9232-433cb3d78b8f 85 fields · synced Jun 18, 2026
- FDA 510(k) K123717 1 fields · synced May 18, 2026