Blunotte 2 Auto
by SXT S.r.l. - Sistemi per Telemedicina Italy EUDAMED
Ref ACPA2, MCPA2Model MCPA
EMDN Z12030102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805771725BLUNOTTED2 | Date17 Jun 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 0425-MDR-030074-00 Issued
Quality management system EU MDR
- Notified body
- ICIM S.P.A. 0425
- Issued
- 10 May 2024
- Expires
- 9 May 2029
Specification
- Trade Name
- Blunotte 2 AutoBlunotte 2
- Model / Reference
- MCPA, ACPA2, MCPA2
- Primary DI / UDI-DI
- 08057717250015, 08057717250008
- Basic UDI-DI
- 805771725BLUNOTTED2
- Direct Marketing DI
- 0805771725001508057717250008
- EMDN Code
- Z12030102 Continuous positive pressure equipment
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000020871
Other devices from SXT S.r.l. - Sistemi per Telemedicina
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 (2)
- EUDAMED 7fb6bd88-6e12-4a7d-a672-2b1b1503f1fc
- EUDAMED 08057717250008|805771725BLUNOTTED2