Identity
- Device Name
- Temporary Pacemaker EUDAMED
- Model / Reference
- 8301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973177880000 EUDAMED
- Basic UDI-DI
- B-06973177880000 EUDAMED
- 510(k) Number
- K182839 FDA 510(k)
- FDA Product Code
- DTE FDA 510(k)
- EMDN Code
- C020299 CARDIAC TEMPORARY STIMULATION DEVICES (WITH OR WITHOUT ACTIVE SUBSTANCES) - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3600 FDA 510(k)
- Regulation Number
- 870.3600 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Temporary Pacemaker by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182839 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K232721 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06973177880000 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000021613
- Authorised Representative
- LifeTech Scientific (Europe) B.V. NL-AR-000000804
Sources (2)
- EUDAMED d9c17625-48c6-4acd-9b26-6043cb5439e1 61 fields · synced Jul 25, 2026
- FDA 510(k) K182839 24 fields · synced May 18, 2026