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Sterile absorbent cotton gauze swabs 5cm x 5cm 17threads/cm2 12 ply bag of 10 s…
EUDAMEDClass I (EU MDR)
Ref H31022Model Compresses stériles de gaze hydrophile
by Adhe-Els SA.
Identity
- Trade Name
- Sterile absorbent cotton gauze swabs 5cm x 5cm 17threads/cm2 12 ply bag of 10 swabs EUDAMED
- Device Name
- Compresses stériles de gaze hydrophile EUDAMED
- Model / Reference
- Compresses stériles de gaze hydrophile EUDAMEDH31022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-H31022VL EUDAMED
- Basic UDI-DI
- B-H31022VL EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intranasal splint, non-biodegradable
Sterile absorbent cotton gauze swabs 5cm x 5cm 17threads/cm2 12 ply bag of 10 s… by Adhe-Els SA. — Class I — MDD — listed in EUDAMED
Similar devices
Also classified as Intranasal splint, non-biodegradable.
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- Custom Nasal Splint — Boston Medical Products, Inc. · Class I
- Doyle II™ — MEDTRONIC XOMED, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-H31022VL | Class I | Active |
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Manufacturer
- Manufacturer
- Adhe-Els SA.
- EUDAMED SRN
- TN-MF-000011757
- Authorised Representative
- ADHE-ELS FRANCE FR-AR-000001654
Sources (1)
- EUDAMED 0492df24-f828-4ca2-8062-996fb07d7eb9 61 fields · synced Jul 24, 2026