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Huntleigh Bd4000xs/Bd4002
EUDAMEDClass I (EU MDR)
Ref ACC-HT210150/200Model Accu-PlusRef SK-HT-210150-200Model SKYMEDRef SK-HT210150-200
Identity
- Trade Name
- HUNTLEIGH BD4000XS/BD4002 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-HT210150/200 EUDAMEDSKYMED EUDAMEDSK-HT-210150-200 EUDAMEDSK-HT210150-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814412 EUDAMED09551026270584 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551019814412 EUDAMED09551026270584 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
Huntleigh Bd4000xs/Bd4002 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 e1562390-d7d4-4573-a667-e4049fca54a5 61 fields · synced Oct 6, 2026
- EUDAMED e9dc7a75-78bd-42a0-9a28-4b72644fe9ec 61 fields · synced May 19, 2026
- EUDAMED 4101eb3f-8a8f-45f9-9db3-d4d6bb7bc137 61 fields · synced Jul 11, 2026