Identity
- Device Name
- Single Use Guide Sheath Kit EUDAMED
- Model / Reference
- HK-202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973592357354 EUDAMED
- Basic UDI-DI
- 697359235ADA2KQ EUDAMED
- Direct Marketing DI
- 06973592357354 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 | 697359235ADA2KQ | 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 e3ebb243-d353-42d2-88b9-9e365b1f5bb0 61 fields · synced Jun 17, 2026