PEA POD Infant Body Composition System PP2025
Ref PP2025
Active
CE MDR
Valid until
23 Oct 2031
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number28620127652-02 | Date24 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00866203000243 | Date16 Apr 2026 | StatusListed |
Certificates
- 28620127652-02 Active
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 24 Oct 2026
- Expires
- 23 Oct 2031
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Pea Pod EUDAMEDPEA POD Infant Body Composition System GUDID
- Generic Name
- Densitometry body composition analyser
- Device Name
- Bod Pod & Pea Pod
- Model / Reference
- PP2025
- Primary DI / UDI-DI
- 00866203000243
- Basic UDI-DI
- 08662030002ADPMT
- 510(k) Number
- FDA Product Code
- OAC
- EMDN Code
- Z12159007 Body plethysmographs
- GMDN Term
- Densitometry body composition analyser
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.2770
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Other devices from Cosmed USA, Inc.
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No