Identity
- Trade Name
- Charder FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Device Name
- Body Composition Analyzer EUDAMED
- Model / Reference
- MA601 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719846016538 EUDAMED04719846005747 EUDAMEDFDA UDI
- Basic UDI-DI
- 471984636022H4 EUDAMED
- FDA Product Code
- PUH FDA UDI
- EMDN Code
- Z12099001 BODY IMPEDANCE ANALYSERS EUDAMED
- GMDN Term
- Bioelectrical body composition analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2770 FDA UDI
- Market of Registration
- Belgium 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Body Composition Analyzer by Charder Electronic Co., Ltd. — Class IIa — 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 | 471984636022H4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Charder Electronic Co. Ltd.
- EUDAMED SRN
- TW-MF-000013673
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 78c9ed21-2e2d-4d61-afbc-7b12ecb5a002 61 fields · synced Jul 10, 2026
- FDA UDI eb023c75-6fe8-4403-a74a-532a2ca546e9 32 fields · synced May 29, 2026
- EUDAMED 535f3626-35ba-4144-b7d2-7b297edae5e7 61 fields · synced Jul 10, 2026