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Ugaiya/Fulcare
EUDAMEDClass I (EU MDR)
Ref UGBI0101Model UGBI0101 UGBI0102 UGBI0103 UGBI0104 UGBI0105 UGBI0106 UGBI0107 UGBI0108 UGBI0109 UGBI0201 UGBI0202 UGBI0203 UGBI0204 UGBI0205 etcRef UGCI0104Model UGCI0104 UGCI0105B UGCI0106 UGCI0105 UGCI0101 UGCI0101B UGCI0101C UGCI0101D UGCI0204 UGCI0201 UGCI0201B UGCI0304 UGCI0305 UGCI0306 UGCI0401 UGCI0504 UGCI0704 FCCI0104 etc
Identity
- Trade Name
- UGAIYA/FULCARE EUDAMED
- Device Name
- Rapid Readout Biological Indicator / Biological Indicator EUDAMEDChemical Indicator EUDAMED
- Model / Reference
- UGBI0101 UGBI0102 UGBI0103 UGBI0104 UGBI0105 UGBI0106 UGBI0107 UGBI0108 UGBI0109 UGBI0201 UGBI0202 UGBI0203 UGBI0204 UGBI0205 etc EUDAMEDUGBI0101 EUDAMEDUGCI0104 UGCI0105B UGCI0106 UGCI0105 UGCI0101 UGCI0101B UGCI0101C UGCI0101D UGCI0204 UGCI0201 UGCI0201B UGCI0304 UGCI0305 UGCI0306 UGCI0401 UGCI0504 UGCI0704 FCCI0104 etc EUDAMEDUGCI0104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976654651001 EUDAMED06976654650004 EUDAMED
- Basic UDI-DI
- 697665465BI01NH EUDAMED697665465CI01NQ EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Ugaiya/Fulcare by Chengdu Fulcare Trading Co., Ltd — 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 | 697665465BI01NH | Class I | Active |
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Manufacturer
- Manufacturer
- Chengdu Fulcare Trading Co., Ltd
- EUDAMED SRN
- CN-MF-000037249
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED d50f3915-4e83-409f-9698-138130c19d38 61 fields · synced Jul 29, 2026
- EUDAMED c33e822b-eae8-4443-97ca-c53655b9a04f 61 fields · synced May 18, 2026