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Carewell 1101/1101g
EUDAMEDClass I (EU MDR)
Ref ACC-5030/16R4Model Accu-PlusRef SK-5030-16R4Model SKYMED
Identity
- Trade Name
- CAREWELL 1101/1101G EUDAMEDCAREWELL ECG ROLL (50MM X 30M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-5030/16R4 EUDAMEDSKYMED EUDAMEDSK-5030-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019813781 EUDAMED09551019812135 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019813781 EUDAMED09551019812135 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
Carewell 1101/1101g 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 4fe1c094-07fa-4518-9745-65f33da8553d 61 fields · synced Jul 12, 2026
- EUDAMED 37a9029e-4823-44b6-a2d4-63c3b2220655 61 fields · synced May 18, 2026
- EUDAMED 3013a834-e93e-4db7-8928-c44cbac70ecf 61 fields · synced Jun 19, 2026