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Lt
EUDAMEDClass I (EU MDR)
Ref LT-PI-610AModel LT-PI-605A,LT-303A,LT-304A,LT-305A,LT-603A,,LT-S-603A,LT-PI-605A,LT-PI-608A,LT-PI-610A,LT-301AH,LT-S-601AH,LT-803AH,LT-301H,LT-606A
Identity
- Trade Name
- LT EUDAMED
- Device Name
- Disposable ECG Electrode EUDAMED
- Model / Reference
- LT-PI-605A,LT-303A,LT-304A,LT-305A,LT-603A,,LT-S-603A,LT-PI-605A,LT-PI-608A,LT-PI-610A,LT-301AH,LT-S-601AH,LT-803AH,LT-301H,LT-606A EUDAMEDLT-PI-610A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945975816601 EUDAMED
- Basic UDI-DI
- 69459758P605ATK EUDAMED
- Unit of Use DI
- 06945975816604 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Lt by Shanghai Litu Medical Appliances Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
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 | 69459758P605ATK | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Litu Medical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000033711
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 3cc550e8-6aa4-4458-b063-fa1b63276455 61 fields · synced Jun 14, 2026