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Defibrillator / Monitor
EUDAMEDClass IIb (EU MDR)
Ref 8199-M20-02-100BModel ZOLL M2
Identity
- Device Name
- Defibrillator / Monitor EUDAMED
- Model / Reference
- ZOLL M2 EUDAMED8199-M20-02-100B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973243970826 EUDAMED
- Basic UDI-DI
- B-06973243970826 EUDAMED
- EMDN Code
- Z12030502 MANUAL DEFIBRILLATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Defibrillator / Monitor by Suzhou ZOLL Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973243970826 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Suzhou ZOLL Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020266
- Authorised Representative
- ZOLL International Holding B.V. NL-AR-000012554
Sources (1)
- EUDAMED 7b880530-8599-40a2-86e9-dcc7992c3ff6 61 fields · synced Jun 18, 2026