Identity
- Device Name
- Single Use Guide Sheath Kit EUDAMED
- Model / Reference
- HK-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973592357347 EUDAMED
- Basic UDI-DI
- 697359235ADA1KN EUDAMED
- Direct Marketing DI
- 06973592357347 EUDAMED
- EMDN Code
- R070208 BRONCHOSCOPIC SURGERY KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Single Use Guide Sheath Kit by Beijing LepuImage Technology 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 | 697359235ADA1KN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing LepuImage Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000026645
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e3d20b7f-1bb1-46c3-a1e4-76432a19a9da 61 fields · synced Jul 10, 2026