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SaCo VLM
EUDAMEDClass IIa (EU MDR)
Ref MLM60CModel DLM10, DLM15, DLM20, DLM25, DLM30, DLM40, DLM50, DLM60, MLM10, MLM15, MLM20, MLM25, MLM30, MLM40, MLM50, MLM60, MLM10C, MLM15C, MLM20C, MLM25C, MLM30C, MLM40C, MLM50C, MLM60C
Identity
- Trade Name
- SaCo VLM EUDAMED
- Device Name
- Disposable Medical Laryngeal Masks EUDAMED
- Model / Reference
- DLM10, DLM15, DLM20, DLM25, DLM30, DLM40, DLM50, DLM60, MLM10, MLM15, MLM20, MLM25, MLM30, MLM40, MLM50, MLM60, MLM10C, MLM15C, MLM20C, MLM25C, MLM30C, MLM40C, MLM50C, MLM60C EUDAMEDMLM60C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937048203527 EUDAMED
- Basic UDI-DI
- 697028348UE000002HZ EUDAMED
- EMDN Code
- R01020199 LARYNGEAL MASKS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
SaCo VLM by Zhejiang UE Medical Corp. — Class IIa — 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 | 697028348UE000002HZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang UE Medical Corp.
- EUDAMED SRN
- CN-MF-000003020
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 634f2c5c-3f16-4a8b-a85f-959df31f511d 61 fields · synced Jul 28, 2026