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Sanatyl, sterilní
EUDAMEDClass I (EU MDR)
Ref 0320/SRef 0314/SRef 0416/SRef 0305/SRef 0306/SRef 0330/SRef 0394/SRef 0310/SRef 0393/SRef 0311/SRef 0302/SRef 0321/SRef 0300/SRef 0313/S
Identity
- Device Name
- Sanatyl, sterilní EUDAMED
- Model / Reference
- 0320/S EUDAMED0314/S EUDAMED0416/S EUDAMED0305/S EUDAMED0306/S EUDAMED0330/S EUDAMED0394/S EUDAMED0310/S EUDAMED0393/S EUDAMED0311/S EUDAMED0302/S EUDAMED0321/S EUDAMED0300/S EUDAMED0313/S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595154114342 EUDAMED08595154114472 EUDAMED08595154114557 EUDAMED08595154114403 EUDAMED08595154114427 EUDAMED08595154114526 EUDAMED08595154114540 EUDAMED08595154114335 EUDAMED08595154114533 EUDAMED08595154114397 EUDAMED08595154114366 EUDAMED08595154114410 EUDAMED08595154114328 EUDAMED08595154114458 EUDAMED
- Basic UDI-DI
- 859515412SANATYLZ2 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
Sanatyl, 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.
- Compresses stériles de gaze hydrophile 8cm x 7cm 17 fils/cm2 - 12 plis sachet de 5 compresses — Adhe-Els SA. · Class I
- Intranasl Splint INS — Boston Medical Products, Inc. · Class I
- Sterile Gauze Balls — Kingstar Medical (Xianning) Co., LTD · Class I
- Sterile Absorbent Pads — GS Medical · Class I
- Sterile Gauze Sponges — JIANGSU FEIXIA MEDICAL PRODUCTS CO., LTD · Class I
- Sterile Pad 9cm x 15cm one fold Without X-Ray ETO sterile — ERMED TIP MEDİKAL TİCARET A.Ş. · Class IIa
- 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 | 859515412SANATYLZ2 | Class I | Active |
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Manufacturer
- Manufacturer
- STERIWUND spol. s r.o.
- EUDAMED SRN
- CZ-MF-000036963
Sources (14)
- EUDAMED 8e7fa6b0-dcc6-4642-853f-ebbd0bcbf361 61 fields · synced Aug 2, 2026
- EUDAMED 7184c688-5b08-477f-a65a-543e9832daa5 61 fields · synced May 16, 2026
- EUDAMED 9aabc675-28af-4820-b18b-ce8af254329f 61 fields · synced May 16, 2026
- EUDAMED 2f1e88f6-c0c3-4e9d-8a4d-1fdbbdf83f3c 61 fields · synced May 17, 2026
- EUDAMED ce130c28-4251-408f-9221-af4e9496d35d 61 fields · synced May 17, 2026
- EUDAMED f4c30378-b5aa-4229-9528-82d3f8292471 61 fields · synced May 17, 2026
- EUDAMED 934110a3-ab81-47fb-9aab-a3afec8c7d13 61 fields · synced May 17, 2026
- EUDAMED d5cc2baa-8688-46fd-a0ad-8a418c8b4b99 61 fields · synced May 18, 2026
- EUDAMED d79fc42f-513a-41be-bc3d-10116b962f7d 61 fields · synced May 18, 2026
- EUDAMED 5ba44739-3ade-4511-a7af-75e6d6998e31 61 fields · synced May 18, 2026
- EUDAMED c21705c5-a191-40b8-8d93-d6f15377f998 61 fields · synced May 18, 2026
- EUDAMED 8c3b0eee-ca69-4242-9ab5-c2f6a450471e 61 fields · synced May 18, 2026
- EUDAMED 5b2681c3-c36b-422e-98c4-121fab22b261 61 fields · synced May 18, 2026
- EUDAMED cc6c88f7-9497-45ef-ae5d-07df833273ad 61 fields · synced May 19, 2026