Pedigo Products, Inc. IVNOW1-EPM-TYPE-H
by Pedigo Products, Inc EUDAMEDGUDID
Active
Ref IVNOW1-EPM-TYPE-H
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number08410271FLUID/BLANKETPF | Date14 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00841027102052 | Date30 Nov 2025 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- Enthermics by Pedigo EUDAMEDPedigo Products, Inc. GUDID
- Generic Name
- Multi-purpose warming cabinet, stationary
- Device Name
- Medical Blanket/Fluid Warming Device
- Model / Reference
- IVNOW1-EPM-TYPE-H
- Primary DI / UDI-DI
- 00841027102052
- Basic UDI-DI
- 08410271FLUID/BLANKETPF
- FDA Product Code
- LGZ
- EMDN Code
- V9099 Various devices not included in other classes - other
- GMDN Term
- Multi-purpose warming cabinet, stationary
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 880.5725
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Other devices from Pedigo Products, 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
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No