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Easy ECG Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PC-80BModel PC-80B、CARDIO-BRef PC-80DModel PC-80D、H600 Ref CARDIO-B
Identity
- Trade Name
- Easy ECG Monitor FDA UDI
- Generic Name
- Electrocardiographic monitor FDA UDI
- Device Name
- Easy ECG Monitor EUDAMED
- Model / Reference
- PC-80B、CARDIO-B EUDAMEDPC-80B EUDAMEDFDA UDIPC-80D、H600 EUDAMEDPC-80D EUDAMEDCARDIO-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941900606630 EUDAMED06941900606647 EUDAMED06941900602502 EUDAMED06941900603066 FDA UDI
- Basic UDI-DI
- 69419006PC80BS01JB EUDAMED69419006PC80D01CV EUDAMED
- Direct Marketing DI
- 06941900606647 EUDAMED06941900602502 EUDAMED
- 510(k) Number
- K073152 FDA UDI
- FDA Product Code
- DSH FDA UDI
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Electrocardiographic monitor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Market of Registration
- Netherlands 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
Easy ECG Monitor by Shenzhen Creative Industry Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69419006PC80BS01JB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
- EUDAMED SRN
- CN-MF-000009430
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (4)
- EUDAMED dec98ea1-8675-4a3f-9bb3-d2cc80e26103 61 fields · synced Jul 27, 2026
- FDA UDI c35efd16-f3f5-4984-93da-e171b9dc3962 33 fields · synced May 30, 2026
- EUDAMED 16c8d6dc-0f7b-4808-8de1-8dfcee70dac3 61 fields · synced Jul 10, 2026
- EUDAMED d9b6e6d7-c9a3-4c2d-93b5-911f130d5f37 61 fields · synced Jul 27, 2026