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Compresses stériles de gaze hydrophile 8cm x 7cm 17 fils/cm2 - 12 plis sachet d…
EUDAMEDClass I (EU MDR)
Ref H31035Model Compresses stériles de gaze hydrophile
by Adhe-Els SA.
Identity
- Trade Name
- Compresses stériles de gaze hydrophile 8cm x 7cm 17 fils/cm2 - 12 plis sachet de 5 compresses EUDAMED
- Device Name
- Compresses stériles de gaze hydrophile EUDAMED
- Model / Reference
- Compresses stériles de gaze hydrophile EUDAMEDH31035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-H31035VV EUDAMED
- Basic UDI-DI
- B-H31035VV 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
Compresses stériles de gaze hydrophile 8cm x 7cm 17 fils/cm2 - 12 plis sachet d… by Adhe-Els SA. — Class I — MDD — listed in EUDAMED
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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-H31035VV | 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 2f527f46-c894-4510-8957-8ea3e8fcd635 61 fields · synced Oct 6, 2026