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Zaragatoa Oral
EUDAMEDClass I (EU MDR)
Ref NROS411Model 10cm, 10.5cm, 11cm, 12cm, 13cm, 13.5cm, 15cm, 15.5cm, 19cmRef NROS412Ref NROS413
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 EUDAMEDNROS412 EUDAMEDNROS413 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976325664115 EUDAMED16976325664122 EUDAMED26976325664136 EUDAMED
- Basic UDI-DI
- 697632566XROSWJ EUDAMED
- Direct Marketing DI
- 16976325664115 EUDAMED16976325664122 EUDAMED26976325664136 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
Zaragatoa Oral by Changzhou Newrise Medical & Hygiene Products 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 | 697632566XROSWJ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013196
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 6ee7c33c-2882-4fa9-9cb9-36dc01633d7e 61 fields · synced Oct 6, 2026
- EUDAMED 3e068e53-83db-4ad1-ada0-269870de31cf 61 fields · synced May 18, 2026
- EUDAMED 3077c12e-0107-4d3a-a205-8f7a6bb50577 61 fields · synced May 19, 2026