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BIOCARE iE12A
EUDAMEDClass I (EU MDR)
Ref SK-BC-210150-200RSModel SKYMEDRef SK-BC210150-200RS
Identity
- Trade Name
- BIOCARE iE12A EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-BC-210150-200RS EUDAMEDSK-BC210150-200RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811800 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019811800 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 iE12A 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-SMPY | 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 (2)
- EUDAMED 04aa047a-9665-4ec2-aa0b-c74d38179ec2 61 fields · synced Jun 19, 2026
- EUDAMED b0cd6e4a-d544-4891-a3a3-09a75f047230 61 fields · synced Jun 19, 2026