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Huntleigh Acc 15
EUDAMEDClass I (EU MDR)
Ref SK-HT-152150-200Model SKYMEDRef ACC-HT152150/200Model Accu-PlusRef SK-HT152150-200Ref APP-HT152150-200Model ALPHA-PLUS
Identity
- Trade Name
- HUNTLEIGH ACC 15 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-HT-152150-200 EUDAMEDAccu-Plus EUDAMEDACC-HT152150/200 EUDAMEDSK-HT152150-200 EUDAMEDALPHA-PLUS EUDAMEDAPP-HT152150-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270577 EUDAMED09551019814405 EUDAMED09551019819790 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551026270577 EUDAMED09551019814405 EUDAMED09551019819790 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 Acc 15 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 (4)
- EUDAMED d9ba0c7b-6d6c-4bb4-a759-770aa1d81ffc 61 fields · synced Oct 1, 2026
- EUDAMED 3e7c10d4-8845-428f-b346-cc2d4deb6b04 61 fields · synced May 17, 2026
- EUDAMED 26fc29cb-46c6-4833-81a5-6bdfd22b8b36 61 fields · synced Jul 18, 2026
- EUDAMED ab95e4d1-bec4-4d7e-b6a0-36ea90b63335 61 fields · synced Jul 18, 2026