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Sleeve
EUDAMEDClass I (EU MDR)
Ref SAP-LG-XLModel SAP-RH-M，SAP-RF-M，SAP-AM-M，MAP-RH-M，MAP-RF-M，MAP-AM-M，MAP-AC-M，SAP-SH-M，MAP-RR-M，MAP-BE-L，SAP-LH-M，SAP-LF-M，SAP-LG-M，SAP-LG-S，SAP-LG-L，MAP-LH-M，MAP-LF-M，MAP-LG-M，MAP-LC-M，MAP-SH-M，MAP-RL-M
Identity
- Trade Name
- Sleeve EUDAMED
- Device Name
- Sleeve EUDAMED
- Model / Reference
- SAP-RH-M，SAP-RF-M，SAP-AM-M，MAP-RH-M，MAP-RF-M，MAP-AM-M，MAP-AC-M，SAP-SH-M，MAP-RR-M，MAP-BE-L，SAP-LH-M，SAP-LF-M，SAP-LG-M，SAP-LG-S，SAP-LG-L，MAP-LH-M，MAP-LF-M，MAP-LG-M，MAP-LC-M，MAP-SH-M，MAP-RL-M EUDAMEDSAP-LG-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984064734 EUDAMED
- Basic UDI-DI
- 6970341680112100GL EUDAMED
- Direct Marketing DI
- 06975984064734 EUDAMED
- EMDN Code
- Z12040285 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Sleeve by Shenzhen Lifotronic 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 | 6970341680112100GL | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 0db095fe-2486-4cb3-ab32-a36ebea947e1 61 fields · synced Jun 18, 2026