Identity
- Trade Name
- Swab EUDAMED
- Device Name
- Swab EUDAMED
- Model / Reference
- ZD003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969980441 EUDAMED06974969980458 EUDAMED
- Basic UDI-DI
- 697496998ZD003YH 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 Biobase Diagnostic Technology (Shandong) 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 | 697496998ZD003YH | Class I | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 2dc8e8e2-940d-4283-9340-69c68aa1c317 61 fields · synced Oct 6, 2026
- EUDAMED 95406dfb-6d67-40e6-aad4-34a26f3f0f66 61 fields · synced May 19, 2026