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Biocare 101/101g
EUDAMEDClass I (EU MDR)
Ref ACC-5030/16R3Model Accu-PlusRef SK-5030-16R3Model SKYMED
Identity
- Trade Name
- BIOCARE 101/101G EUDAMEDBIOCARE ECG ROLL (50MM X 30M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-5030/16R3 EUDAMEDSKYMED EUDAMEDSK-5030-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019813347 EUDAMED09551019812210 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019813347 EUDAMED09551019812210 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
Biocare 101/101g 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 803a2e50-da99-4462-aa60-f2ed87b41d69 61 fields · synced Aug 3, 2026
- EUDAMED e6c3e459-0222-4990-b2e8-a24e80b7ddec 61 fields · synced May 19, 2026
- EUDAMED 1867b58f-f6cf-41a2-9b39-20d66f8fdbcd 61 fields · synced Jun 11, 2026