Identity
- Trade Name
- Charder FDA UDI
- Generic Name
- Infant scale, electronic FDA UDI
- Device Name
- Infant Scale EUDAMED
- Model / Reference
- MS21NEOV EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719846015807 EUDAMED04719846003675 FDA UDI
- Basic UDI-DI
- 471984635324HG EUDAMED
- FDA Product Code
- FRW FDA UDI
- EMDN Code
- Z12080402 NEONATAL SCALES EUDAMED
- GMDN Term
- Infant scale, electronic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.2720 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
Infant Scale by Charder Electronic Co., Ltd. — 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 | 471984635324HG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (2)
- EUDAMED c60f8503-dea2-4a10-8656-7f6c176f36dd 61 fields · synced Jul 13, 2026
- FDA UDI ac1e237a-be07-4364-a352-31bced60cc91 32 fields · synced May 30, 2026