Identity
- Trade Name
- Skin Shape EUDAMED
- Device Name
- Skin Shape 312 EUDAMED
- Model / Reference
- 312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649995521089 EUDAMED
- Basic UDI-DI
- 7649995521RFSSHUH EUDAMED
- Direct Marketing DI
- 07649995521089 EUDAMED
- EMDN Code
- G030699 DEVICES FOR THE NON-SURGICAL TREATMENT OF OBESITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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 | 7649995521RFSSHUH | 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 8891ca8a-6ec2-4ee0-b88b-5e27ef990122 61 fields · synced Jun 18, 2026