Identity
- Trade Name
- LBTK-M-I 5004T EUDAMED
- Device Name
- Intermittent Pneumatic Compression Units EUDAMED
- Model / Reference
- LBTK-M-I 5001 EUDAMEDLBTK-M-I 5004T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971599071051 EUDAMED
- Basic UDI-DI
- 697159907LBTK-M-I500XXSJ EUDAMED
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Lbtk-M-I 5004t by Dalian Labtek Science & Development Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697159907LBTK-M-I500XXSJ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dalian Labtek Science & Development Co., Ltd.
- EUDAMED SRN
- CN-MF-000042341
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1c84b0e5-953c-4685-9884-d61a2d700432 61 fields · synced Oct 6, 2026