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Zoll 8000-0300
EUDAMEDClass I (EU MDR)
Ref ACC-Z9090/200RSModel Accu-PlusRef SK-Z9090-200RSModel SKYMEDRef APP-Z9090-200RSModel ALPHA-PLUS
Identity
- Trade Name
- ZOLL 8000-0300 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-Z9090/200RS EUDAMEDSKYMED EUDAMEDSK-Z9090-200RS EUDAMEDALPHA-PLUS EUDAMEDAPP-Z9090-200RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811169 EUDAMED09551019810643 EUDAMED09551026273578 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019811169 EUDAMED09551019810643 EUDAMED09551026273578 EUDAMED
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Zoll 8000-0300 by Isd Meditech Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955101981MCRP-APNG | Class I | Active |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 5fd68714-caa2-4bcd-afe1-8edd85e1b4de 61 fields · synced Jul 15, 2026
- EUDAMED 0abf795c-a888-4c5a-9052-d3b7f6066640 61 fields · synced May 17, 2026
- EUDAMED 3d58a859-abdc-4f47-be1b-a99b68dbee5a 61 fields · synced Jul 11, 2026