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Digital Electrocardiograph
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 90130148-01Model iE 300
Identity
- Trade Name
- Digital Electrocardiograph EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Digital Electrocardiograph EUDAMED
- Model / Reference
- iE 300 EUDAMED90130148-01 EUDAMEDiE300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06937683412377 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06937683412377 EUDAMED
- 510(k) Number
- K160092 FDA UDI
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Digital Electrocardiograph by Shenzhen Biocare Bio-Medical Equipment Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06937683412377 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000005653
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 75b76b19-93aa-41d7-badb-346c72d8a3fc 61 fields · synced May 31, 2026
- FDA UDI 46d61b46-5f76-46a8-8c01-2db6d29f0443 33 fields · synced May 30, 2026