Identity
- Trade Name
- Aesthesio EUDAMED
- Device Name
- Aesthesio EUDAMED
- Model / Reference
- 514004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850006095223 EUDAMED
- Basic UDI-DI
- 0850006095Aesthesio5R EUDAMED
- Direct Marketing DI
- 00850006095223 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Aesthesio by Danmic Global, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0850006095Aesthesio5R | Class I | Active |
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Manufacturer
- Manufacturer
- Danmic Global, LLC
- EUDAMED SRN
- US-MF-000021060
- Authorised Representative
- Code of Practice AB SE-AR-000003002
Sources (1)
- EUDAMED 27aae123-3163-48b4-bee8-056cd634e29c 61 fields · synced Jun 18, 2026