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Zoll 901000003
EUDAMEDClass I (EU MDR)
Ref ACC-Z80120/180RModel Accu-PlusRef SK-Z80120-180RModel SKYMEDRef APP-Z80120-180RModel ALPHA-PLUS
Identity
- Trade Name
- ZOLL 901000003 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-Z80120/180R EUDAMEDSKYMED EUDAMEDSK-Z80120-180R EUDAMEDALPHA-PLUS EUDAMEDAPP-Z80120-180R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019815372 EUDAMED09551026271574 EUDAMED09551026273561 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019815372 EUDAMED09551026271574 EUDAMED09551026273561 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 901000003 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 8cd42878-3c4d-40cb-97c6-a3bf5ed3f4bf 61 fields · synced Jul 9, 2026
- EUDAMED f350adf8-560b-4d84-a16f-841e973f834d 61 fields · synced May 18, 2026
- EUDAMED 0f044658-20e2-495e-8939-d4c3bae1dc09 61 fields · synced Jun 20, 2026