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Sleeve
EUDAMEDClass I (EU MDR)
Ref MAP-BE-LModel 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-MRef SAP-LG-MRef MAP-LG-MRef SAP-LG-LRef SAP-SH-MRef SAP-SH-XLRef MAP-AM-MRef SAP-LH-MRef SAP-SH-LRef MAP-LC-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 EUDAMEDMAP-BE-L EUDAMEDSAP-LG-M EUDAMEDMAP-LG-M EUDAMEDSAP-LG-L EUDAMEDSAP-SH-M EUDAMEDSAP-SH-XL EUDAMEDMAP-AM-M EUDAMEDSAP-LH-M EUDAMEDSAP-SH-L EUDAMEDMAP-LC-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984060040 EUDAMED06975984064666 EUDAMED16975984060146 EUDAMED06970341686253 EUDAMED16975984061266 EUDAMED06975984060170 EUDAMED06975984060378 EUDAMED06975984060026 EUDAMED16975984060115 EUDAMED06975984060163 EUDAMED06975984060354 EUDAMED06975984064642 EUDAMED16975984060139 EUDAMED06975984060156 EUDAMED
- Basic UDI-DI
- 6970341680112100GL EUDAMED
- Direct Marketing DI
- 06975984060040 EUDAMED06975984064666 EUDAMED16975984060146 EUDAMED06970341686253 EUDAMED16975984061266 EUDAMED06975984060170 EUDAMED06975984060378 EUDAMED06975984060026 EUDAMED16975984060115 EUDAMED06975984060163 EUDAMED06975984060354 EUDAMED06975984064642 EUDAMED16975984060139 EUDAMED06975984060156 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 (14)
- EUDAMED bcd0ca66-03c9-4f92-9630-882221e93e2b 61 fields · synced Aug 1, 2026
- EUDAMED e42f6d7d-8e43-4f3a-971c-d0b08452ed25 61 fields · synced May 16, 2026
- EUDAMED 8a576c8b-ea70-4b34-9b26-5ebf6cdcd5bf 61 fields · synced May 17, 2026
- EUDAMED e0c9fc65-e227-43b1-bdc4-f61337cdc2aa 61 fields · synced May 17, 2026
- EUDAMED 07572557-e5f5-4c75-94f9-745acd1a661c 61 fields · synced May 17, 2026
- EUDAMED 32f30524-584d-4fe1-868a-f06a2481e8d4 61 fields · synced May 18, 2026
- EUDAMED 16eeda58-424a-4f64-bec4-e6d352c81ccf 61 fields · synced May 18, 2026
- EUDAMED 22ed13ed-41b8-4568-bb96-43df9896426f 61 fields · synced May 18, 2026
- EUDAMED 449fab24-1799-483e-8bc7-9562cf173ae0 61 fields · synced May 18, 2026
- EUDAMED e0b8f3eb-8e7f-44e9-bf76-32fb658b9530 61 fields · synced May 19, 2026
- EUDAMED 4c0f61bc-c856-4888-89a5-53bd68b25b0c 61 fields · synced May 19, 2026
- EUDAMED 9d80be46-767f-466a-9903-7b9b90271ad7 61 fields · synced May 19, 2026
- EUDAMED be820b7f-b5cd-440d-bf90-3f243c042883 61 fields · synced May 19, 2026
- EUDAMED d4f4e7af-085e-4edc-85ba-f18e7f9a9f7f 61 fields · synced May 19, 2026