Identity
- Trade Name
- ACOFAR EUDAMED
- Device Name
- GASA NO ESTÉRIL 20H EUDAMED
- Model / Reference
- 4838596 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435081585962 EUDAMED
- Basic UDI-DI
- 843508154838F3 EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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: Intranasal splint, non-biodegradable
Acofar by Ortopedia y Cirugía, S.L. — 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 | 843508154838F3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortopedia y Cirugía, S.L.
- EUDAMED SRN
- ES-MF-000016977
Sources (1)
- EUDAMED 24ee9210-d96a-47b8-bc61-35c84e499e0b 61 fields · synced Jul 29, 2026