Identity
- Device Name
- Specimen Collection Swab EUDAMED
- Model / Reference
- NA EUDAMEDRB2821 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973069980085 EUDAMED26973069980096 EUDAMED16973069980570 EUDAMED26973069980911 EUDAMED
- Basic UDI-DI
- 697306998SCSABSRBM EUDAMED697306998DSSABSORS2 EUDAMED697306998SCSEOVM EUDAMED
- Unit of Use DI
- 36973069980093 EUDAMED36973069980574 EUDAMED36973069980918 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMEDU089002 DEVICES FOR GYNAECOLOGICAL CYTOLOGY EUDAMED
Classification
- Device Class
- Class I 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
Category: General-purpose absorbent tip applicator/swab, single-use
Specimen Collection Swab by Dalian Rongbang Medical Healthy Devices Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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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 | 697306998SCSABSRBM | Class I | Active |
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Manufacturer
- Manufacturer
- Dalian Rongbang Medical Healthy Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000022752
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 1357a47f-42ce-43df-994d-e77ae804396d 61 fields · synced Aug 4, 2026
- EUDAMED 331d5bc9-fc12-4e48-9364-d5d9e2229f51 61 fields · synced May 18, 2026
- EUDAMED 35d36b4a-87e2-471c-af3d-bd696cf89fbc 61 fields · synced May 18, 2026
- EUDAMED f96de59b-b96e-4142-918d-20d2f47cc486 61 fields · synced May 19, 2026