Identity
- Trade Name
- Aprikos Medical EUDAMED
- Device Name
- Gyneocological Examination Inst. EUDAMED
- Model / Reference
- AM18-124-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07073371092991 EUDAMED
- Basic UDI-DI
- 7073371FILE107LK EUDAMED
- Direct Marketing DI
- 07073371092991 EUDAMED
- EMDN Code
- L0509020199 GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Fixed-diameter cervical dilator, reusable
Aprikos Medical by Aprikos Medical AS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Fixed-diameter cervical dilator, reusable.
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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 | 7073371FILE107LK | Class I | Active |
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Manufacturer
- Manufacturer
- Aprikos Medical AS
- EUDAMED SRN
- NO-MF-000044411
Sources (1)
- EUDAMED bf07ea55-5d49-4f59-a2d9-94d5796031f2 61 fields · synced Jun 18, 2026