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PEA POD Infant Body Composition System
EUDAMEDFDA UDIClass I (EU MDR)
Ref PEA POD
Identity
- Trade Name
- PEA POD Infant Body Composition System EUDAMEDPEA POD® Infant Body Composition System FDA UDI
- Generic Name
- Densitometry body composition analyser FDA UDI
- Device Name
- BOD POD & PEA POD EUDAMEDThe PEA POD® Infant Body Composition System (“PEA POD”) is indicated for measuring the body mass and estimating the body composition (i.e., percent and absolute amounts of fat and lean body mass) of subjects between 1 and 8 kilograms. It is not intended for use with subjects requiring life support. FDA UDI
- Model / Reference
- PEA POD EUDAMEDPEA POD Infant Body Composition System FDA UDI
- Description
- The PEA POD® Infant Body Composition System (“PEA POD”) is indicated for measuring the body mass and estimating the body composition (i.e., percent and absolute amounts of fat and lean body mass) of subjects between 1 and 8 kilograms. It is not intended for use with subjects requiring life support. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866203000229 EUDAMEDFDA UDI
- Basic UDI-DI
- 08662030002ADPMT EUDAMED
- 510(k) Number
- K032610 FDA UDI
- FDA Product Code
- OAC FDA UDI
- EMDN Code
- Z12159007 BODY PLETHYSMOGRAPHS EUDAMED
- GMDN Term
- Densitometry body composition analyser FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2770 FDA UDI
- Market of Registration
- Italy 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
PEA POD Infant Body Composition System by Cosmed Usa, Inc. — 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 | 08662030002ADPMT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- COSMED USA, Inc.
- EUDAMED SRN
- US-MF-000011304
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED d0a630c1-06d8-4188-b6a1-2612a6af43de 61 fields · synced Jun 20, 2026
- FDA UDI aa523b0b-36b1-4470-9a99-4ce149cb81da 36 fields · synced May 30, 2026