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Aptos
EUDAMEDClass IIb (EU MDR)
Ref AN4.0030Model Sole Otoplasty N
by Aptos LLC
Identity
- Trade Name
- APTOS EUDAMED
- Device Name
- Aptos Threads - Non Absorbable Surgical Sutures EUDAMED
- Model / Reference
- Sole Otoplasty N EUDAMEDAN4.0030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 4860120240115 EUDAMED
- Basic UDI-DI
- B-4860120240115 EUDAMED
- EMDN Code
- H010201010401 POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Aptos by Aptos, LLC — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-4860120240115 | Class IIb | Active |
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Manufacturer
Sources (1)
- EUDAMED c119c1d9-24bd-4efa-af41-c0c87e74135f 61 fields · synced May 23, 2026