← Back to catalogue
Electrocardiograph
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref iSE-1210Ref SE-12Ref SE-1202Ref eSE-300Ref SE-12 ExpressRef SE-300BRef SE-310Ref SE-15Ref SE-300ARef SE-1200 ProRef SE-3Ref SE-1202ERef iSE-1810Ref SE-1200Ref CS-1201
Identity
- Trade Name
- Electrocardiograph EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- iSE-1210 EUDAMEDSE-12 EUDAMEDFDA UDISE-1202 EUDAMEDSE-3 EUDAMEDFDA UDISE-12 Express EUDAMEDFDA UDISE-300A EUDAMEDFDA UDISE-1200 EUDAMEDFDA UDIeSE-300 EUDAMEDSE-300B EUDAMEDSE-310 EUDAMEDSE-15 EUDAMEDSE-1200 Pro EUDAMEDSE-1202E EUDAMEDiSE-1810 EUDAMEDCS-1201 EUDAMEDSE-1200Pro FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413812239 EUDAMED06944413800359 EUDAMEDFDA UDI06944413847422 EUDAMED06944413800304 EUDAMEDFDA UDI06944413800366 EUDAMEDFDA UDI06944413800311 EUDAMEDFDA UDI06944413820616 EUDAMEDFDA UDI06944413800373 EUDAMEDFDA UDI06944413844506 EUDAMED06944413844520 EUDAMED06944413844490 EUDAMED06944413802223 EUDAMED06944413844919 EUDAMED06944413812246 EUDAMED06944413828681 EUDAMED
- Basic UDI-DI
- 69444138iSES3X EUDAMED69444138SE12SPJ EUDAMED69444138SE1202GG EUDAMED69444138SE310sLF EUDAMED69444138SE15SPT EUDAMED69444138SE3SUC EUDAMED69444138SE1201PROS8Y EUDAMED69444138SE1201GE EUDAMED
- 510(k) Number
- K222902 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
- 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
Electrocardiograph 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 | K210140 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69444138iSES3X | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (22)
- EUDAMED e79a6d47-8511-42be-8263-2430de43879b 61 fields · synced Sep 17, 2026
- EUDAMED 455bd6c2-f334-4b4d-9163-a3271446d3e5 61 fields · synced May 18, 2026
- EUDAMED c719a77f-783b-4e8d-b03b-b0f11f026f24 61 fields · synced May 18, 2026
- FDA UDI de8d82ac-b3dd-4beb-aa06-e962eca0b6d7 32 fields · synced May 29, 2026
- FDA UDI 2065bfe9-1ffa-43d4-8f3f-2d8a5f4f75c3 32 fields · synced May 30, 2026
- FDA UDI 35034df5-b10a-4bfe-acf8-02c2cf7335f1 32 fields · synced May 30, 2026
- FDA UDI e7afdee0-2bd1-4067-a542-3eb26bfa8038 33 fields · synced May 30, 2026
- FDA UDI bda961c2-5b9f-4ca1-b3ee-59ffbd43f8d9 32 fields · synced May 30, 2026
- FDA UDI 512df333-d41e-4575-a819-7b3a912d2f27 32 fields · synced May 30, 2026
- EUDAMED ea63989f-5068-4775-a64e-a20b6b368b9b 61 fields · synced Jul 9, 2026
- EUDAMED 7a8dc835-7aaf-40cb-8eca-d8bdc48d822f 61 fields · synced Jul 9, 2026
- EUDAMED 324febad-c675-4182-97eb-09892c31a67d 61 fields · synced Jul 9, 2026
- EUDAMED a7c64f16-7548-45b5-b517-3df9e9514d35 61 fields · synced Jul 10, 2026
- EUDAMED cc8b6ba7-395a-4f7b-bd59-164fdac7930c 61 fields · synced Jul 11, 2026
- EUDAMED 7454f903-5782-4fc0-a604-e308b290019a 61 fields · synced Jul 17, 2026
- EUDAMED d8710200-1803-442d-a34a-d2493e86a6b0 61 fields · synced Jul 20, 2026
- EUDAMED e41043dd-fd3c-4c0f-9743-5acb08651223 61 fields · synced Jul 22, 2026
- EUDAMED 25bae513-df3c-4b14-a58c-6b50397ab4d8 61 fields · synced Jul 23, 2026
- EUDAMED 2f695122-b77c-4f33-91a3-756e4ac49deb 61 fields · synced Jul 26, 2026
- EUDAMED 727affb0-b8a4-4f5c-8636-2a9d5b9c1ee8 61 fields · synced Jul 29, 2026
- EUDAMED e583f876-5ac0-4802-b370-3a25d684f7c4 61 fields · synced Sep 17, 2026
- FDA 510(k) K210140 1 fields · synced May 18, 2026