Otter Conductive Warmer
by Medical Technology Transfer and Services Company Limited Vietnam EUDAMED
Ref Otter
EMDN Z12080407
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberPP11684OTTER37 | Date25 Feb 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2026-MDR/QS-008 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 26 Jan 2026
- Expires
- 19 Jan 2029
Specification
- Device Name
- Infant Conductive Warmer
- Model / Reference
- Otter
- Primary DI / UDI-DI
- 111927727650
- Basic UDI-DI
- PP11684OTTER37
- Direct Marketing DI
- 28935378190069
- EMDN Code
- Z12080407 Neonatal radiant warmers
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- VN-MF-000036669
- Authorised representative
- Logic S.r.l. IT-AR-000012301
From the manufacturer
Manufacturer's product page: Otter Warmer
Other devices from Medical Technology Transfer and Services Company Limited
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: 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
Sources (1)
- EUDAMED 03610357-c88a-4087-92b3-b7836d9cc581