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Space Labs 006-0196-00
EUDAMEDClass I (EU MDR)
Ref SK-SP-50120-230SModel SKYMEDRef APP-SP50120-230SModel ALPHA-PLUSRef SK-SP50120-230S
Identity
- Trade Name
- SPACE LABS 006-0196-00 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-SP-50120-230S EUDAMEDALPHA-PLUS EUDAMEDAPP-SP50120-230S EUDAMEDSK-SP50120-230S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271413 EUDAMED09551026273431 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551026271413 EUDAMED09551026273431 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
Space Labs 006-0196-00 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 | 955102627MCRP-SMMG | 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 62abcdb4-850a-42d5-8b1f-2573d7f38885 61 fields · synced Jul 21, 2026
- EUDAMED 43f500e6-a51e-4e1f-8180-045443b3e8ce 61 fields · synced Jul 10, 2026
- EUDAMED ba421ee5-6bdc-4756-b994-a07401beab64 61 fields · synced Jul 21, 2026