Identity
- Trade Name
- Skin Shape EUDAMED
- Device Name
- Skin Shape EUDAMED
- Model / Reference
- 311 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649995521027 EUDAMED
- Basic UDI-DI
- 7649995521RFV8 EUDAMED
- Direct Marketing DI
- 07649995521027 EUDAMED
- EMDN Code
- G030699 DEVICES FOR THE NON-SURGICAL TREATMENT OF OBESITY - 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
Skin Shape by Top Engineering Sarl — 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 | 7649995521RFV8 | Class I | Active |
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Manufacturer
- Manufacturer
- Top Engineering Sarl
- EUDAMED SRN
- CH-MF-000027119
- Authorised Representative
- QS MEDICAL DEVICE REGISTRATION LTD CY-AR-000024665
Sources (1)
- EUDAMED e059cb33-7d4e-423a-9164-91c1e29926a2 61 fields · synced Jun 18, 2026