Identity
- Trade Name
- SG Brush EUDAMED
- Model / Reference
- GS-1 & GS-2 EUDAMEDT5721 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069157217 EUDAMED
- Basic UDI-DI
- B-08800069157217 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose absorbent tip applicator/swab, single-use
SG Brush by SG BioScience Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800069157217 | Class I | Active |
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Manufacturer
- Manufacturer
- SG BioScience Inc.
- EUDAMED SRN
- KR-MF-000009362
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 57675343-11fc-48d1-a3a7-c093525895a5 61 fields · synced Jun 18, 2026