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ECG Cable

EUDAMEDFDA UDI

Class I (EU MDR)

Ref RPAYACC028Ref EL03DICY101Ref MECG-ASRef iT30-EL5DACHO1Ref DECG-QRef RPAYACC018Ref MECG-3ISRef RPAYACC020Ref RPAYACC029Ref RPAYACC033Ref RPAYACC026Ref RPAYACC012Ref RPAYACC013Ref RPAYACC021Ref RPAYACC014Ref DECG-WTRef RPAYACC016Ref EC05DIS1211Ref RPAYACC001Ref iT30-EL3DISHO1Ref RPAYACC009Ref MECG-AGRef iT30-EL6DISHO1Ref 01.57.471744Ref iT30-EL6DACHO1Ref ET10DIS1211Ref iT30-EL5DASHO1Ref iT30-EL5DICHO1Ref RPAYACC023Ref DECG-WQRef RPAYACC024Ref RPAYACC010Ref RPAYACC006Ref EC03DAS1211Ref MECG-3ASRef RPAYACC003Ref DECG-WPRef iT30-EL12DISHO1Ref RPAYACC030Ref RPAYACC005Ref EL5NASHO1Ref EL12DISY101Ref EC10DABDS1BRef 01.57.471998Ref 01.57.471613Ref EL10DIB181Ref EC10DABDX1Ref EC10DISHD1Ref 01.57.471999Ref EL06DAB181Ref EL06DIB181Ref EC10DASDX1Ref EL5NISHO1Ref EL10DAB181Ref EL16DAB181Ref EC07DISHD1Ref EC07DASHD1Ref EL05DACY101Ref EC10DIBHD1Ref EC10DISDX1Ref EL10NISHD1Ref EL7NISHO1Ref EL16DIB181Ref 01.57.471876Ref EC10DISDS1Ref EL7NASHD1Ref EL03DACY101Ref EL06DICY101Ref EL05DICY101Ref EL10NASHD1Ref EC10DASDS2Ref 01.57.471877Ref EL06DACY101Ref EC10DIBDS1E

by Edan Instruments, Inc.

Identity

Trade Name
ECG Cable EUDAMEDFDA UDI
Holter ECG Cable FDA UDI
RespArray ECG trunk cable FDA UDI
Dx12 exercise ECG Cable FDA UDI
Dx12 ECG Cable FDA UDI
Exercise ECG Cable FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Electrical-only medical device connection cable, reusable FDA UDI
Device Name
ECG Cable EUDAMED
Model / Reference
RPAYACC028 EUDAMED
EL03DICY101 EUDAMED
MECG-AS EUDAMED
iT30-EL5DACHO1 EUDAMED
DECG-Q EUDAMED
RPAYACC018 EUDAMED
MECG-3IS EUDAMED
RPAYACC020 EUDAMED
RPAYACC029 EUDAMED
RPAYACC033 EUDAMED
RPAYACC026 EUDAMED
RPAYACC012 EUDAMED
RPAYACC013 EUDAMED
RPAYACC021 EUDAMED
RPAYACC014 EUDAMED
DECG-WT EUDAMED
RPAYACC016 EUDAMED
EC05DIS1211 EUDAMED
RPAYACC001 EUDAMED
iT30-EL3DISHO1 EUDAMED
RPAYACC009 EUDAMED
MECG-AG EUDAMED
iT30-EL6DISHO1 EUDAMED
01.57.471744 EUDAMED
iT30-EL6DACHO1 EUDAMED
ET10DIS1211 EUDAMED
iT30-EL5DASHO1 EUDAMED
iT30-EL5DICHO1 EUDAMED
RPAYACC023 EUDAMED
DECG-WQ EUDAMED
RPAYACC024 EUDAMED
RPAYACC010 EUDAMED
RPAYACC006 EUDAMED
EC03DAS1211 EUDAMED
MECG-3AS EUDAMED
RPAYACC003 EUDAMED
DECG-WP EUDAMED
iT30-EL12DISHO1 EUDAMED
RPAYACC030 EUDAMED
RPAYACC005 EUDAMED
EL5NASHO1 EUDAMED
EL12DISY101 EUDAMED
EC10DABDS1B EUDAMED
01.57.471998 EUDAMED
01.57.471613 EUDAMED
EL10DIB181 EUDAMED
EC10DABDX1 EUDAMED
EC10DISHD1 EUDAMED
01.57.471999 EUDAMED
EL06DAB181 EUDAMED
EL06DIB181 EUDAMED
EC10DASDX1 EUDAMED
EL5NISHO1 EUDAMED
EL10DAB181 EUDAMED
EL16DAB181 EUDAMED
EC07DISHD1 EUDAMED
EC07DASHD1 EUDAMED
EL05DACY101 EUDAMED
EC10DIBHD1 EUDAMED
EC10DISDX1 EUDAMED
EL10NISHD1 EUDAMED
EL7NISHO1 EUDAMED
EL16DIB181 EUDAMED
01.57.471876 EUDAMED
EC10DISDS1 EUDAMED
EL7NASHD1 EUDAMED
EL03DACY101 EUDAMED
EL06DICY101 EUDAMED
EL05DICY101 EUDAMED
EL10NASHD1 EUDAMED
EC10DASDS2 EUDAMED
01.57.471877 EUDAMED
EL06DACY101 EUDAMED
EC10DIBDS1E EUDAMED
3-Lead, snap stye, AHA, reusable FDA UDI
12-Lead,Ф4mm,banana,IEC,reusable FDA UDI
3-Lead, snap stye, IEC, reusable FDA UDI
01.57.472331 FDA UDI
12-Lead, snap, AHA, reusable FDA UDI
18-Lead, Ф4mm Banana, AHA, reusable FDA UDI
12-Lead,IEC, Ф4mm Banana, reusable FDA UDI
12-electrode, Banana Ф4mm, IEC FDA UDI
12-Lead,Ф4mm,banana,AHA,reusable FDA UDI
12-Lead, snap, IEC, reusable FDA UDI
18-Lead, Ф4mm Banana, IEC, reusable FDA UDI
12-Lead, Ф4mm Banana, AHA, reusable FDA UDI
12-Lead, AHA, Ф4mm Banana, reusable FDA UDI

Identifiers

Primary DI / UDI-DI
16944413825076 EUDAMED
06944413847156 EUDAMED
06944413802780 EUDAMED
06944413830653 EUDAMED
06944413807655 EUDAMED
16944413824925 EUDAMED
06944413812826 EUDAMED
16944413824932 EUDAMED
16944413824956 EUDAMED
16944413824970 EUDAMED
16944413825069 EUDAMED
16944413824888 EUDAMED
16944413825038 EUDAMED
16944413824741 EUDAMED
16944413824895 EUDAMED
06944413802858 EUDAMED
16944413824918 EUDAMED
06944413830882 EUDAMED
16944413824826 EUDAMED
06944413830585 EUDAMED
16944413825014 EUDAMED
06944413802797 EUDAMED
06944413830660 EUDAMED
06944413813281 EUDAMED
06944413830691 EUDAMED
06944413830912 EUDAMED
06944413830639 EUDAMED
06944413830646 EUDAMED
16944413824758 EUDAMED
06944413802766 EUDAMED
16944413824796 EUDAMED
16944413824871 EUDAMED
16944413824994 EUDAMED
06944413830899 EUDAMED
06944413812819 EUDAMED
06944413824744 EUDAMEDFDA UDI
16944413824840 EUDAMED
06944413802773 EUDAMED
06944413830707 EUDAMED
16944413825083 EUDAMED
16944413824987 EUDAMED
06944413803657 EUDAMEDFDA UDI
06944413808904 EUDAMEDFDA UDI
06944413803640 EUDAMEDFDA UDI
06944413803503 EUDAMEDFDA UDI
06944413803572 EUDAMEDFDA UDI
06944413803374 EUDAMEDFDA UDI
06944413803299 EUDAMEDFDA UDI
06944413803756 EUDAMEDFDA UDI
06944413808911 EUDAMEDFDA UDI
06944413803282 EUDAMEDFDA UDI
06944413803626 EUDAMEDFDA UDI
06944413803589 EUDAMEDFDA UDI
06944413803251 EUDAMEDFDA UDI
06944413803305 EUDAMEDFDA UDI
06944413803534 EUDAMEDFDA UDI
06944413847255 EUDAMED
06944413811904 EUDAMED
06944413803794 EUDAMED
06944413831360 EUDAMED
06944413811911 EUDAMED
06944413803824 EUDAMED
06944413803817 EUDAMED
06944413803800 EUDAMED
06944413831384 EUDAMED
06944413831391 EUDAMED
06944413847200 EUDAMED
06944413831421 EUDAMED
06944413821330 EUDAMED
06944413821361 EUDAMED
06944413847163 EUDAMED
06944413847231 EUDAMED
06944413847194 EUDAMED
06944413821347 EUDAMED
06944413847248 EUDAMED
Basic UDI-DI
69444138ECGCablePWJ EUDAMED
69444138ECGCable2UQ EUDAMED
69444138ECGCableOWG EUDAMED
69444138ECGCableEVU EUDAMED
510(k) Number
K220308 FDA UDI
FDA Product Code
DSA FDA UDI
EMDN Code
Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Electrocardiographic lead set, reusable FDA UDI
Electrical-only medical device connection cable, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.2900 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

No

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

Yes

FDA UDI

Serial Number

Yes

FDA UDIFDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrical-only medical device connection cable, reusable

ECG Cable by Edan Instruments, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrical-only medical device connection cable, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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 (91)

  • EUDAMED f6483724-045b-4329-bf42-4e7493506526 61 fields · synced Sep 18, 2026
  • EUDAMED 0ab53fb5-7bb8-4306-a092-4194a04eeedd 61 fields · synced May 11, 2026
  • EUDAMED d3142d76-081c-46ca-be28-70f90a0bdbc5 61 fields · synced May 16, 2026
  • EUDAMED 802b9bfa-deb2-47a1-8142-a081629604a6 61 fields · synced May 16, 2026
  • EUDAMED fc3fede0-b6d2-4273-b94e-c1fef7532e3f 61 fields · synced May 16, 2026
  • EUDAMED ea9153b2-1de0-4741-a05b-5953d9ac8f7e 61 fields · synced May 17, 2026
  • EUDAMED 67494b4d-07c7-46da-9c2c-ff2f799ff349 61 fields · synced May 17, 2026
  • EUDAMED 1b4893cd-c2c2-4670-9f94-434b2371a2b6 61 fields · synced May 17, 2026
  • EUDAMED be2c33d6-65b2-4289-b2a2-0515fef4ba7b 61 fields · synced May 17, 2026
  • EUDAMED bd176704-d8e3-48f7-bfa9-82fa9c87272d 61 fields · synced May 17, 2026
  • EUDAMED f77e09af-aa63-4dc8-b529-440b1fadacc8 61 fields · synced May 17, 2026
  • EUDAMED 2743ae26-5fae-4768-8398-23d63f6205cf 61 fields · synced May 17, 2026
  • EUDAMED c2b24cd4-c5e4-4591-a7e7-374f299d5909 61 fields · synced May 17, 2026
  • EUDAMED 036bc670-0ee5-4f19-87b0-e39ed60a2f27 61 fields · synced May 17, 2026
  • EUDAMED 51c20be0-bdd5-413d-bb4f-fbf9fdee742b 61 fields · synced May 17, 2026
  • EUDAMED 77dd798f-6ebc-4881-81b1-057464d57a10 61 fields · synced May 17, 2026
  • EUDAMED 008fa347-9993-420a-a86b-eaa590f13d61 61 fields · synced May 17, 2026
  • EUDAMED 64598367-e850-497d-a4c2-ec3184f4d10b 61 fields · synced May 17, 2026
  • EUDAMED a3c54bba-fcf2-4ba7-9cbe-f0cab9b1f3e5 61 fields · synced May 17, 2026
  • EUDAMED cdc4ce4c-bff4-4683-ba1d-14cc514b5179 61 fields · synced May 17, 2026
  • EUDAMED 251c2261-edd4-4a67-9af8-1d6e717842cd 61 fields · synced May 17, 2026
  • EUDAMED 6c1a25cd-973e-45ee-9cbb-335da9627f35 61 fields · synced May 18, 2026
  • EUDAMED 6da91a3b-bd9b-40b0-a012-456e05a0a692 61 fields · synced May 18, 2026
  • EUDAMED b7532c66-077f-4896-8a6f-170c10f36182 61 fields · synced May 18, 2026
  • EUDAMED 2b7857f4-1981-410b-bfc4-d7326b9bab23 61 fields · synced May 18, 2026
  • EUDAMED 614412b9-23a6-405e-ac2a-ab2bb7f0181e 61 fields · synced May 18, 2026
  • EUDAMED 23085fc7-0001-473e-8535-f01a00300ff0 61 fields · synced May 18, 2026
  • EUDAMED 04357a27-81d0-41d3-9909-eeb0c311f5c9 61 fields · synced May 18, 2026
  • EUDAMED c8c0a851-0d3d-4720-a105-78608835f3dd 61 fields · synced May 18, 2026
  • EUDAMED 853b2eb0-7da9-48af-8d77-a00bfe40321f 61 fields · synced May 19, 2026
  • EUDAMED 92743395-758c-4e7f-9058-77f2873cc4ae 61 fields · synced May 19, 2026
  • EUDAMED b9250c04-e9bb-4fb4-a550-37449651e06d 61 fields · synced May 19, 2026
  • EUDAMED 5f5a67bb-c309-4514-a461-01d3a41c17e9 61 fields · synced May 19, 2026
  • EUDAMED efd1c7c9-0061-40ba-b8a0-7d17b675d90b 61 fields · synced May 19, 2026
  • EUDAMED 1d9b7479-94c1-4814-b30a-78f8cd69ecb7 61 fields · synced May 19, 2026
  • EUDAMED 9d5b0495-db56-40a5-8fef-4cffbf736d1f 61 fields · synced May 19, 2026
  • EUDAMED d65b506c-ad75-4eaa-8fe0-7f0b1b1d85e9 61 fields · synced May 19, 2026
  • EUDAMED 02953760-36c1-4ac6-9ce7-f88c3543b993 61 fields · synced May 19, 2026
  • EUDAMED 3b31beef-2b40-44ff-a5c7-fe30b4b97b80 61 fields · synced May 19, 2026
  • EUDAMED f545db75-f47f-4b09-9b3d-b9fede8208ea 61 fields · synced May 19, 2026
  • EUDAMED a0ff19f9-9de2-43cc-b4ce-ebce06a41f7b 61 fields · synced May 19, 2026
  • FDA UDI 14f8a73f-29ed-4962-8510-377ea707c63b 32 fields · synced May 22, 2026
  • FDA UDI 453b1bdc-380b-46d5-8d6b-16e92376182e 32 fields · synced May 29, 2026
  • FDA UDI 87c34b7c-fcc7-4508-b4d3-ce0fcc6f2af0 32 fields · synced May 29, 2026
  • FDA UDI d6b6d5b7-6f17-48ff-98f6-2d931dd92835 33 fields · synced May 29, 2026
  • FDA UDI 461ec6aa-a8ce-4661-ae38-348a6becad75 32 fields · synced May 30, 2026
  • FDA UDI 3c77d5e4-b37d-46b0-91a8-4029345c9569 32 fields · synced May 30, 2026
  • FDA UDI d85ab4c8-9a4d-49fc-9dba-635053414250 32 fields · synced May 30, 2026
  • FDA UDI 718b016e-4a95-4c63-bd51-19583e4caf9c 32 fields · synced May 30, 2026
  • FDA UDI 2dcb21ec-ac81-46b0-8e19-879095acc1c2 32 fields · synced May 30, 2026
  • FDA UDI ea6505bf-b3c3-4d73-b0a5-75fb59f5b896 32 fields · synced May 30, 2026
  • FDA UDI 73d695d1-9539-4552-b60a-90d6d5d77343 32 fields · synced May 30, 2026
  • FDA UDI bccf70b2-959f-4874-9a67-d024cfbc5f92 32 fields · synced May 30, 2026
  • FDA UDI 8a6f3760-8a4e-4a4c-8ce8-59e36ba5266b 32 fields · synced May 30, 2026
  • FDA UDI 3e25b63a-43fd-4343-b282-9b1f26b62103 32 fields · synced May 30, 2026
  • FDA UDI fc336cfe-f656-4985-82c2-bf61fc174734 32 fields · synced May 30, 2026
  • FDA UDI ef60a8fa-445a-4987-b47d-07a273b76818 32 fields · synced May 30, 2026
  • EUDAMED de4430cb-97f5-41ac-9328-8d75a3ccd86c 61 fields · synced Jun 20, 2026
  • EUDAMED 077f881d-3f45-4ef1-84a5-83022145ce10 61 fields · synced Jul 9, 2026
  • EUDAMED d642efb6-1ed2-4cd5-a96f-62261bcec67a 61 fields · synced Jul 9, 2026
  • EUDAMED dd3ef0a8-ec83-478c-91f4-ae981fcf40c2 61 fields · synced Jul 9, 2026
  • EUDAMED 47bba255-1c63-4f6f-8cab-128811cc5c30 61 fields · synced Jul 9, 2026
  • EUDAMED 29886a24-bcad-434b-bbae-913ee57c90df 61 fields · synced Jul 9, 2026
  • EUDAMED 8074db09-b9a8-438e-b3fd-69a7018d83d8 61 fields · synced Jul 9, 2026
  • EUDAMED 7715ca52-2661-4336-97d0-dd2186d72f5a 61 fields · synced Jul 11, 2026
  • EUDAMED 357acda6-ef20-4792-a1d2-f9c07a37ffee 61 fields · synced Jul 11, 2026
  • EUDAMED 0dea3707-4856-492c-8787-ba6d55059370 61 fields · synced Jul 11, 2026
  • EUDAMED 32ccf337-15bb-419b-afef-d16c9ef9395f 61 fields · synced Jul 11, 2026
  • EUDAMED 26a5b78a-ae22-4a1e-aabe-2b3aecc63b04 61 fields · synced Jul 11, 2026
  • EUDAMED 5097387f-c89b-4251-84e4-e948ee8c1511 61 fields · synced Jul 11, 2026
  • EUDAMED 0eac089e-28b5-4960-a660-7ecac4d504f3 61 fields · synced Jul 13, 2026
  • EUDAMED c0b57a22-05ae-4f5d-b18c-e2089101295b 61 fields · synced Jul 14, 2026
  • EUDAMED dae7a5dd-f8c6-4d01-a86d-9b5bce893574 61 fields · synced Jul 16, 2026
  • EUDAMED 1a44bc9d-02db-4820-8919-49c9f32cb0ee 61 fields · synced Jul 16, 2026
  • EUDAMED d55297e6-abfa-4c2b-87a4-ec31dc123c96 61 fields · synced Jul 17, 2026
  • EUDAMED 967135d6-bc5e-41b4-933a-22aa168fd035 61 fields · synced Jul 17, 2026
  • EUDAMED 21cdd114-23fd-49d2-ac3c-1c3c6b48745e 61 fields · synced Jul 17, 2026
  • EUDAMED 9056aabf-9340-46c3-af1e-f67f1b661bb5 61 fields · synced Jul 19, 2026
  • EUDAMED fbd3bffc-8d06-43c7-b0ad-f39082a9f6e4 61 fields · synced Jul 20, 2026
  • EUDAMED 56a19a30-4682-4d9f-a471-8baf8ed04673 61 fields · synced Jul 23, 2026
  • EUDAMED 6b6dbf0d-a40f-4d0a-9ebd-228a1cdee808 61 fields · synced Jul 23, 2026
  • EUDAMED 61022fb8-f10d-4985-b540-2c124098dfee 61 fields · synced Jul 25, 2026
  • EUDAMED d6e33547-e844-412f-bbb0-e0987cbd0c84 61 fields · synced Jul 26, 2026
  • EUDAMED 519da1f3-154a-4629-bb7c-1d2b27ef0d1e 61 fields · synced Jul 27, 2026
  • EUDAMED 5c460fcc-baa8-41cc-8bad-9c6cce9e5f7c 61 fields · synced Jul 28, 2026
  • EUDAMED c52f6f07-a451-47d3-9309-54858ccca701 61 fields · synced Jul 29, 2026
  • EUDAMED c15110e4-16db-4412-99be-01a06d7d58d0 61 fields · synced Aug 1, 2026
  • EUDAMED d390654a-21cd-4126-921c-18521ccf19e9 61 fields · synced Aug 2, 2026
  • EUDAMED 15bcb4cd-d7a1-46d2-94f0-696e27707d80 61 fields · synced Aug 2, 2026
  • EUDAMED 778cc481-a4d1-4361-bb02-837050e20674 61 fields · synced Aug 2, 2026
  • EUDAMED 5c56a1ce-7850-4f37-aab6-005027c414b4 61 fields · synced Sep 17, 2026