Termometr bezdotykowy
by Shenzhen Pango Medical Electronics Co., Ltd EUDAMED
Active
Ref V0301010202Model PG-IRT1603、PG-IRT1613、PG-IRT1615
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6948423814320B4 | Date25 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 28620184373-02 Supplemented
Quality management system EU MDR
- Notified body
- Intertek Medical Notified Body AB 2862
- Issued
- 20 Aug 2026
- Expires
- 25 Jul 2029
- Reason
- Other
Specification
- Device Name
- Infrared Ear/Forehead Thermometer
- Model / Reference
- PG-IRT1603、PG-IRT1613、PG-IRT1615, V0301010202
- Primary DI / UDI-DI
- 06948423815235
- Basic UDI-DI
- 6948423814320B4
- Direct Marketing DI
- 06948423815235
- EMDN Code
- V0301010202 Non-contact digital thermometers
- Device Class
- Class IIa
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000023018
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shenzhen Pango Medical Electronics Co., Ltd
See all devices from Shenzhen Pango Medical Electronics Co., Ltd →
Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No