Identity
- Trade Name
- AST Medical EUDAMED
- Device Name
- sterile wound dressing EUDAMED
- Model / Reference
- 1030 EUDAMEDTM16143 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926365597846 EUDAMED
- Basic UDI-DI
- 69263655100037H EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
AST Medical 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 | 69263655100037H | 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 9cc90bdc-8d07-4a94-847f-5498324e429f 61 fields · synced Jun 11, 2026