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Space Labs 307 568
EUDAMEDClass I (EU MDR)
Ref ACC-SP120150/200SModel Accu-PlusRef SK-SP-120150-200SModel SKYMEDRef SK-SP120150-200S
Identity
- Trade Name
- SPACE LABS 307 568 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-SP120150/200S EUDAMEDSKYMED EUDAMEDSK-SP-120150-200S EUDAMEDSK-SP120150-200S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019815259 EUDAMED09551026271420 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551019815259 EUDAMED09551026271420 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 307 568 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 ddb7662d-6cce-483c-8f86-d22df53faa6e 61 fields · synced Jul 21, 2026
- EUDAMED 6dc20207-7c2b-44ee-8b84-b02899e26b9a 61 fields · synced May 19, 2026
- EUDAMED 53d7d587-fa60-4ff7-bc5e-e321ea9c160f 61 fields · synced Jul 21, 2026