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Disposable Swabs for Nasopharyngeal Sampling
EUDAMEDClass I (EU MDR)
Ref 101;102Model Disposable Swabs
Identity
- Device Name
- Disposable Swabs for Nasopharyngeal Sampling EUDAMED
- Model / Reference
- Disposable Swabs EUDAMED101;102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975960541003 EUDAMED
- Basic UDI-DI
- 697596054100P8 EUDAMED
- Direct Marketing DI
- 16975960541003 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
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
Disposable Swabs for Nasopharyngeal Sampling by Azubio Diagnostics Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
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- ESCOB.FLOCK NASOF. 80MM FLOW — Deltalab, S.L. · Class I
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 | 697596054100P8 | Class I | Active |
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Manufacturer
- Manufacturer
- Azubio Diagnostics Co., Ltd
- EUDAMED SRN
- CN-MF-000032581
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 80d417ec-b058-4333-b9af-d5e0a493046b 61 fields · synced Jul 19, 2026
- EUDAMED 80d417ec-b058-4333-b9af-d5e0a493046b-1 61 fields · synced Jun 10, 2026