Identity
- Trade Name
- Swab EUDAMED
- Device Name
- Swab EUDAMED
- Model / Reference
- BH007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974901971124 EUDAMED
- Basic UDI-DI
- 6974901BH007UA EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Swab by Shandong Bohong Gene Technology Co., Ltd. — Class I — 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 | 6974901BH007UA | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Bohong Gene Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025971
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 405fc932-b81f-439b-950e-07750622b26e 61 fields · synced Jun 19, 2026