Defibrillator / Monitor
by Suzhou ZOLL Medical Technology Co., Ltd. 25 variants
Ref 8199-M20-04-200A, 8199-M20-02-300A, 8199-M20-23-200A, 8199-M20-02-400B, 8199-M20-00-150B, 8199-M20-04-100A, 8199-M20-04-300A, 8199-M20-00-100A, 8199-M20-11-400B, 8199-M20-04-100B, 8199-M20-23-150B, 8199-M20-11-150A, 8199-M20-23-400B, 8199-M20-11-300B, 8199-M20-23-300A, 8199-M20-02-100A, 8199-M20-23-150A, 8199-M20-23-200B, 8199-M20-02-500B, 8199-M20-04-150B, 8199-M20-04-200B, 8199-M20-11-300A, 8199-M20-11-100A, 8199-M20-00-500B, 8199-M20-02-150B, 8199-M20-00-400B, 8199-M20-55-150AModel ZOLL M2
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06973243970956 | Date8 Nov 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Defibrillator / MonitorMonitor/Defibrillator
- Model / Reference
- ZOLL M2, 8199-M20-04-200A, 8199-M20-02-300A, 8199-M20-23-200A, 8199-M20-02-400B, 8199-M20-00-150B, 8199-M20-04-100A, 8199-M20-04-300A, 8199-M20-00-100A, 8199-M20-11-400B, 8199-M20-04-100B, 8199-M20-23-150B, 8199-M20-11-150A, 8199-M20-23-400B, 8199-M20-11-300B, 8199-M20-23-300A, 8199-M20-02-100A, 8199-M20-23-150A, 8199-M20-23-200B, 8199-M20-02-500B, 8199-M20-04-150B, 8199-M20-04-200B, 8199-M20-11-300A, 8199-M20-11-100A, 8199-M20-00-500B, 8199-M20-02-150B, 8199-M20-00-400B, 8199-M20-55-150A
- Primary DI / UDI-DI
- 06973243970956, 06973243970871, 06973243970253, 06973243970895, 06973243970048, 06973243970918, 06973243970970, 06973243970017, 06973243971090, 06973243970925, 06973243970246, 06973243971038, 06973243970291, 06973243971083, 06973243970277, 06973243970819, 06973243970239, 06973243970260, 06973243970901, 06973243970949, 06973243970963, 06973243971076, 06973243971014, 06973243970109, 06973243970840, 06973243970093, 06973243970437
- Basic UDI-DI
- B-06973243970956, B-06973243970871, B-06973243970253, B-06973243970895, B-06973243970048, B-06973243970918, B-06973243970970, B-06973243970017, B-06973243971090, B-06973243970925, B-06973243970246, B-06973243971038, B-06973243970291, B-06973243971083, B-06973243970277, B-06973243970819, B-06973243970239, B-06973243970260, B-06973243970901, B-06973243970949, B-06973243970963, B-06973243971076, B-06973243971014, B-06973243970109, B-06973243970840, B-06973243970093, B-06973243970437
- EMDN Code
- Z12030502 Manual defibrillators
- Device Class
- Class IIb
- EU market of registration
- PolandFranceSpainItalyNetherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000020266
- Authorised representative
- ZOLL International Holding B.V. NL-AR-000012554
Other devices from Suzhou ZOLL Medical Technology Co., Ltd.
See all devices from Suzhou ZOLL Medical Technology Co., Ltd. →
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No