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Burdick 79 69
EUDAMEDClass I (EU MDR)
Ref SK-B2-10300-200RS1Model SKYMEDRef ACC-B210300/200RS1Model Accu-PlusRef APP-B210300-200RS1Model ALPHA-PLUSRef SK-B210300-200RS1
Identity
- Trade Name
- BURDICK 79 69 EUDAMEDBURDICK 7969 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-B2-10300-200RS1 EUDAMEDAccu-Plus EUDAMEDACC-B210300/200RS1 EUDAMEDALPHA-PLUS EUDAMEDAPP-B210300-200RS1 EUDAMEDSK-B210300-200RS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271581 EUDAMED09551019813545 EUDAMED09551019818816 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551026271581 EUDAMED09551019813545 EUDAMED09551019818816 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
Burdick 79 69 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 f77a4944-2bcf-4146-bb93-0d881aeefb22 61 fields · synced Jul 22, 2026
- EUDAMED 8ddcc301-8075-4eac-b299-cd0f4376879c 61 fields · synced May 18, 2026
- EUDAMED 6a7d6104-0d53-4236-9533-08fe07614dbf 61 fields · synced Jun 20, 2026
- EUDAMED 49d98d65-0701-476c-b43b-429402bbfd26 61 fields · synced Jul 19, 2026