Identity
- Trade Name
- Safe+ Sound health EUDAMED
- Device Name
- Skin closure strips EUDAMED
- Model / Reference
- 5038 EUDAMEDSA4126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926365591073 EUDAMED
- Basic UDI-DI
- 69263655100027F EUDAMED
- EMDN Code
- H900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Safe+ Sound health by Zhejiang Longterm Medical Technology Co., Ltd. — 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 | 69263655100027F | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Longterm Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001161
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b9272e38-b8c1-4160-97dc-b2d5fb0b57b6 61 fields · synced Oct 6, 2026