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Corometrics Aao 4483
EUDAMEDClass I (EU MDR)
Ref ACC-CO14045/20R4Model Accu-PlusRef SK-CO-14045-20R4Model SKYMEDRef SK-CO14045-20R4
Identity
- Trade Name
- COROMETRICS AAO 4483 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-CO14045/20R4 EUDAMEDSKYMED EUDAMEDSK-CO-14045-20R4 EUDAMEDSK-CO14045-20R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019813897 EUDAMED09551019812234 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019813897 EUDAMED09551019812234 EUDAMED
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMEDZ12050385 ELECTROCARDIOGRAPHS - CONSUMABLES 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
Corometrics Aao 4483 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 fac4e31a-94dd-412a-bdc5-66188a84594b 61 fields · synced Jul 15, 2026
- EUDAMED 89e80b51-8ce7-43d9-b382-e93bc31ced47 61 fields · synced May 17, 2026
- EUDAMED 8e0d49fd-7331-4e5d-b364-f5835e8bbab3 61 fields · synced Jul 13, 2026