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Disposable ECG Electrodes
EUDAMEDClass I (EU MDR)
Ref TF01Model TF01,TF02,TF03,TF04,TF05,TF06,TF07,TF08,TF09,TF10,TF11,TF12,TF13,TF14,TF15,TF16, TN01,TN02,TN03,TN04,TN05,TN06,TN07,TN08,TN08,TN09, etcRef TR02Ref TR04Ref TR01Ref TF06Ref TW03Ref TL04Ref TW13Ref TX06Ref TW14Ref TW08Ref TN16Ref TF16Ref TN01Ref TB03Ref TL01Ref TL03Ref TX12Ref TW04Ref TX07Ref TW01Ref TN09Ref TF03Ref TX14Ref TN04Ref TF11Ref TW10Ref TL02Ref TF13Ref TR03Ref TF08Ref TW11Ref TN12Ref TX11Ref TX13Ref TX15Ref TW15Ref TX09Ref TN11Ref TX01Ref TF09Ref TN15Ref TW09Ref TW12
Identity
- Device Name
- Disposable ECG Electrodes EUDAMED
- Model / Reference
- TF01,TF02,TF03,TF04,TF05,TF06,TF07,TF08,TF09,TF10,TF11,TF12,TF13,TF14,TF15,TF16, TN01,TN02,TN03,TN04,TN05,TN06,TN07,TN08,TN08,TN09, etc EUDAMEDTF01 EUDAMEDTR02 EUDAMEDTR04 EUDAMEDTR01 EUDAMEDTF06 EUDAMEDTW03 EUDAMEDTL04 EUDAMEDTW13 EUDAMEDTX06 EUDAMEDTW14 EUDAMEDTW08 EUDAMEDTN16 EUDAMEDTF16 EUDAMEDTN01 EUDAMEDTB03 EUDAMEDTL01 EUDAMEDTL03 EUDAMEDTX12 EUDAMEDTW04 EUDAMEDTX07 EUDAMEDTW01 EUDAMEDTN09 EUDAMEDTF03 EUDAMEDTX14 EUDAMEDTN04 EUDAMEDTF11 EUDAMEDTW10 EUDAMEDTL02 EUDAMEDTF13 EUDAMEDTR03 EUDAMEDTF08 EUDAMEDTW11 EUDAMEDTN12 EUDAMEDTX11 EUDAMEDTX13 EUDAMEDTX15 EUDAMEDTW15 EUDAMEDTX09 EUDAMEDTN11 EUDAMEDTX01 EUDAMEDTF09 EUDAMEDTN15 EUDAMEDTW09 EUDAMEDTW12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978812870002 EUDAMED06978812870705 EUDAMED06978812870729 EUDAMED06978812870699 EUDAMED06978812870057 EUDAMED06978812870514 EUDAMED06978812870682 EUDAMED06978812870613 EUDAMED06978812870385 EUDAMED06978812870620 EUDAMED06978812870569 EUDAMED06978812870323 EUDAMED06978812870156 EUDAMED06978812870163 EUDAMED06978812870750 EUDAMED06978812870651 EUDAMED06978812870675 EUDAMED06978812870446 EUDAMED06978812870521 EUDAMED06978812870392 EUDAMED06978812870491 EUDAMED06978812870255 EUDAMED06978812870026 EUDAMED06978812870460 EUDAMED06978812870194 EUDAMED06978812870101 EUDAMED06978812870583 EUDAMED06978812870668 EUDAMED06978812870125 EUDAMED06978812870712 EUDAMED06978812870071 EUDAMED06978812870590 EUDAMED06978812870286 EUDAMED06978812870439 EUDAMED06978812870453 EUDAMED06978812870477 EUDAMED06978812870637 EUDAMED06978812870415 EUDAMED06978812870279 EUDAMED06978812870330 EUDAMED06978812870088 EUDAMED06978812870316 EUDAMED06978812870576 EUDAMED06978812870606 EUDAMED
- Basic UDI-DI
- 697881287ECGELECTRODESQ3 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Electrocardiographic electrode, single-use
Disposable ECG Electrodes by Shanghai Heramed Tech Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697881287ECGELECTRODESQ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Heramed Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048531
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (44)
- EUDAMED d7b4eb96-fb87-433d-bab0-5c66083ce70f 61 fields · synced Sep 17, 2026
- EUDAMED 15b8da15-9f59-4dcc-85ca-976af815dc39 61 fields · synced Jun 14, 2026
- EUDAMED 522250c0-0d99-4f83-85d1-53d01cc08cbd 61 fields · synced Jun 18, 2026
- EUDAMED 5567b82f-eb6b-4eb9-9b44-828855eddb3e 61 fields · synced Jun 18, 2026
- EUDAMED 4a9dc23a-2b82-41c3-9453-b1db4e180907 61 fields · synced Jun 20, 2026
- EUDAMED 2ddec52e-1b2b-4007-82e6-8e8ef00591ce 61 fields · synced Jul 9, 2026
- EUDAMED ba7bd37b-02a9-4d59-85b6-ef8154c99d82 61 fields · synced Jul 9, 2026
- EUDAMED 12a4e85d-af3d-45fc-991c-59ecb4809eb7 61 fields · synced Jul 9, 2026
- EUDAMED 09adb460-521a-4d87-a6de-846574bab397 61 fields · synced Jul 10, 2026
- EUDAMED bb22b235-3ec2-4db8-85a1-e7768aaf78e8 61 fields · synced Jul 10, 2026
- EUDAMED 15a29c54-d09c-497c-a6a6-46aeecba3560 61 fields · synced Jul 11, 2026
- EUDAMED d19e58b9-2028-4970-af4d-7696e9ab9276 61 fields · synced Jul 11, 2026
- EUDAMED 09cd2687-2c81-4dce-8d3f-e969d79ae4c0 61 fields · synced Jul 12, 2026
- EUDAMED b8f63563-f787-4193-8083-84cfc0825416 61 fields · synced Jul 12, 2026
- EUDAMED 86e8bfd5-e3cb-4862-a309-1b8972f5ade8 61 fields · synced Jul 13, 2026
- EUDAMED 2050f8a7-d9c4-495c-8978-21f981e504b0 61 fields · synced Jul 13, 2026
- EUDAMED fce4c2c6-b81d-4c31-ae72-67a8afd914c6 61 fields · synced Jul 13, 2026
- EUDAMED a3462616-96ed-4dec-b37d-12057574a9b1 61 fields · synced Jul 13, 2026
- EUDAMED a10d6fb8-4302-49ec-b9a1-d3a9e068812f 61 fields · synced Jul 13, 2026
- EUDAMED bef764d9-41f7-499b-9fa3-100bd7ca2373 61 fields · synced Jul 14, 2026
- EUDAMED a3664f53-3f3f-483f-9dda-2aaac6445d98 61 fields · synced Jul 14, 2026
- EUDAMED bc108445-9589-48ec-a51a-97881daa774c 61 fields · synced Jul 14, 2026
- EUDAMED 3832672d-05ed-48d5-9529-6b85d8d1bbf0 61 fields · synced Jul 14, 2026
- EUDAMED 30f7fcf9-8f97-4f5f-9114-cdb7ecf86e38 61 fields · synced Jul 15, 2026
- EUDAMED 84e77e9b-3ce3-4f6f-a981-b880f11dfb12 61 fields · synced Jul 15, 2026
- EUDAMED f0f6cf84-3ee0-4ec1-8fde-5c1b188b1c27 61 fields · synced Jul 15, 2026
- EUDAMED 11612098-efd5-48a8-8fb9-1ce7510b93b6 61 fields · synced Jul 17, 2026
- EUDAMED 2fff868d-555c-4e4b-80d3-ea939e0e2886 61 fields · synced Jul 20, 2026
- EUDAMED beb184ac-749a-4d8a-acaf-2e56924888a7 61 fields · synced Jul 20, 2026
- EUDAMED 4cc5d7fd-5a66-4e5a-979f-79c5df6ebacf 61 fields · synced Jul 20, 2026
- EUDAMED 4795f4d5-ccd0-4824-88eb-67ba5cd0addd 61 fields · synced Jul 21, 2026
- EUDAMED 73fae02f-d32c-49a9-a64b-e8e64523bcb5 61 fields · synced Jul 22, 2026
- EUDAMED 1d7ccbc8-b2a0-42d7-a94e-5d57f1f6c334 61 fields · synced Jul 22, 2026
- EUDAMED 447091e2-d0c3-4bbf-bd98-240ae020880b 61 fields · synced Jul 22, 2026
- EUDAMED 8fc19c9c-7936-40f4-a0e9-d1ba3d7e7ded 61 fields · synced Jul 23, 2026
- EUDAMED b5accfe3-a39e-49c9-9159-69529b831490 61 fields · synced Jul 24, 2026
- EUDAMED ce1d8207-6345-4d19-8b2d-644bfb1490ea 61 fields · synced Jul 25, 2026
- EUDAMED 56c47857-2aa0-4552-b837-b9b1165baeef 61 fields · synced Jul 26, 2026
- EUDAMED 873c539d-e716-4058-9d91-af7e0ea77a91 61 fields · synced Jul 28, 2026
- EUDAMED a42db045-2966-4384-bbc6-c2d972bc9024 61 fields · synced Jul 28, 2026
- EUDAMED 89c2efd8-05c5-4333-8e17-be750de7436b 61 fields · synced Jul 30, 2026
- EUDAMED 23f0920a-1faa-4231-8ef9-2ea8fb25fd13 61 fields · synced Jul 31, 2026
- EUDAMED 19e79a0a-377f-4857-a7a4-e070cb5233d1 61 fields · synced Aug 2, 2026
- EUDAMED 669451af-1ea9-4b2b-8356-4db346ccb4f0 61 fields · synced Sep 17, 2026