Identity
- Trade Name
- Tampon stáčený, sterilní EUDAMED
- Device Name
- Tampony, sterilní EUDAMED
- Model / Reference
- 0446 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595154104060 EUDAMED
- Basic UDI-DI
- 859515410TAMPONPW EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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: Intranasal splint, non-biodegradable
Tampon stáčený, sterilní by STERIWUND spol. s r.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intranasal splint, non-biodegradable.
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- Gauze Swabs — Jiujiang HuaDa Medical Dressing Co., Ltd. · Class I
- Custom Nasal Splint — Boston Medical Products, Inc. · 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 | 859515410TAMPONPW | Class I | Active |
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Manufacturer
- Manufacturer
- STERIWUND spol. s r.o.
- EUDAMED SRN
- CZ-MF-000036963
Sources (1)
- EUDAMED 4121c24b-b644-4be5-91cc-adb0ee66c137 61 fields · synced Jun 17, 2026