Identity
- Trade Name
- Clarius Charger HD3 EUDAMEDClarius Ultrasound Scanner FDA UDI
- Generic Name
- Noninvasive device battery charger FDA UDI
- Device Name
- Clarius Charger EUDAMEDAccessory - Charger for Clarius Ultrasound Scanner FDA UDI
- Model / Reference
- 99-13-00030 EUDAMEDClarius Charger HD3 FDA UDI
- Description
- Accessory - Charger for Clarius Ultrasound Scanner FDA UDI
Identifiers
- Catalog Number
- 99-13-00030, 99-03-00023 FDA UDI
- Primary DI / UDI-DI
- 07540205001349 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540205ClariusCharger6F EUDAMED
- Direct Marketing DI
- 07540205001349 EUDAMED
- 510(k) Number
- K213436 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Noninvasive device battery charger FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Clarius Charger HD3 by Clarius Mobile Health Corp. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540205ClariusCharger6F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clarius Mobile Health Corp.
- EUDAMED SRN
- CA-MF-000037016
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7afbebc7-bde7-461a-a95c-e46903d6b396 61 fields · synced Jun 18, 2026
- FDA UDI 16e1cfec-c086-40d0-8880-f57d7f12f86b 35 fields · synced May 30, 2026