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Holter ECG and ABP system
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SA-20Ref SA-18 Ref SA-15Ref SA-16
Identity
- Trade Name
- Holter ECG and ABP system EUDAMEDFDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDIElectrocardiographic ambulatory recorder FDA UDI
- Device Name
- Holter ECG and ABP system EUDAMED
- Model / Reference
- SA-20 EUDAMEDFDA UDISA-15 EUDAMEDFDA UDISA-16 EUDAMEDFDA UDISA-18 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413820500 EUDAMEDFDA UDI06944413820463 EUDAMEDFDA UDI06944413820470 EUDAMEDFDA UDI06944413820487 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138SA20SNM EUDAMED
- 510(k) Number
- K230184 FDA UDI
- FDA Product Code
- DSH FDA UDIDXN FDA UDI
- EMDN Code
- Z12050402 MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.) EUDAMED
- GMDN Term
- Blood pressure ambulatory recorder FDA UDIElectrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI870.1130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Holter ECG and ABP system by Edan Instruments, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230184 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69444138SA20SNM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (9)
- EUDAMED 56b551ac-3038-4a79-ad14-32f926144602 61 fields · synced Jul 28, 2026
- FDA UDI 37d33c62-7d1f-4534-a791-f04b2802ae35 33 fields · synced May 29, 2026
- FDA UDI d66e9218-b19a-41b1-8b4b-4cac7da92679 33 fields · synced May 30, 2026
- FDA UDI 672c748a-3eba-4e68-a3da-34095a483e35 33 fields · synced May 30, 2026
- FDA UDI 23838eba-1a0a-4579-9786-181b66515b9f 33 fields · synced May 30, 2026
- EUDAMED 97e02d4d-c22b-47b7-8c47-babd1a59a559 61 fields · synced Jul 12, 2026
- EUDAMED 025e7f81-6f7a-42bc-9dc2-5e30bcec1bf9 61 fields · synced Jul 14, 2026
- EUDAMED e350865b-6553-4efd-8022-9eb9d8838349 61 fields · synced Jul 28, 2026
- FDA 510(k) K230184 1 fields · synced May 18, 2026