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Zaragatoa Oral
EUDAMEDClass I (EU MDR)
Ref NROS411Model 10cm, 10.5cm, 11cm, 12cm, 13cm, 13.5cm, 15cm, 15.5cm, 19cm
Identity
- Trade Name
- Zaragatoa Oral EUDAMED
- Device Name
- Oral Swab EUDAMED
- Model / Reference
- 10cm, 10.5cm, 11cm, 12cm, 13cm, 13.5cm, 15cm, 15.5cm, 19cm EUDAMEDNROS411 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26976325664112 EUDAMED
- Basic UDI-DI
- 697632566XROSWJ EUDAMED
- Direct Marketing DI
- 26976325664112 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Category: General-purpose absorbent tip applicator/swab, single-use
Zaragatoa Oral by Changzhou Newrise Medical & Hygiene Products 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.
- Disposable Sterile Swabs — Hangzhou Yiguoren Biotechnology Co.,Ltd. · Class I
- NATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc. · Class I
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- ESCOB. PS FLOCK NASOF. 80MM EN TUBO — Deltalab, S.L. · Class IIa
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- Microbrush — YOUNG MICROBRUSH LLC · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
- 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 | 697632566XROSWJ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013196
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 90b8f1f2-7b52-48cb-b117-e09fcfcda85b 61 fields · synced Jun 19, 2026