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Self-Suction-LEM
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref A.5670Model LEMRef A.5670.3LFRef A.5670.5LFDRef A.5670.5LF
by Sapi Med Spa
Identity
- Trade Name
- LEM SELF SUCTION EUDAMEDSelf-Suction-LEM FDA UDI
- Generic Name
- Haemorrhoid ligator FDA UDI
- Device Name
- Ligator EUDAMEDSELF-SUCTION LEM - Disposable haemorrhoid banding ligator with auto suction. Complete with 3 bands. FDA UDI
- Model / Reference
- LEM EUDAMEDA.5670 EUDAMEDA.5670.3LF EUDAMEDA.5670.5LFD EUDAMEDA.5670.5LF EUDAMEDSelf-Suction-LEM with 3 bands FDA UDI
- Description
- SELF-SUCTION LEM - Disposable haemorrhoid banding ligator with auto suction. Complete with 3 bands. FDA UDI
Identifiers
- Catalog Number
- A.5670.3 FDA UDI
- Primary DI / UDI-DI
- 08033638801710 EUDAMED08033638803325 EUDAMED08033638803639 EUDAMED08033638803165 EUDAMED08033638803301 FDA UDI
- Basic UDI-DI
- 803363880LEMASPDJ EUDAMED803363880LEMAUTOASPEB EUDAMED
- 510(k) Number
- K070881 FDA UDI
- FDA Product Code
- FHN FDA UDI
- EMDN Code
- G020401 HAEMORRHOID LIGATURE SETS EUDAMED
- GMDN Term
- Haemorrhoid ligator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haemorrhoid ligator
Self-Suction-LEM by Sapi Med Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Haemorrhoid ligator.
- V. Mueller — STERIS CORPORATION · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- Sklar® — Sklar Corporation · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
- ESI — FTT MEDICAL, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sapi Med Spa
Sources (5)
- FDA UDI a7c90498-7a47-46ac-9269-f0e53a4f68b1 35 fields · synced Aug 4, 2026
- EUDAMED 05e966fa-c76c-4678-bb6d-313c55990eaf 61 fields · synced Jul 9, 2026
- EUDAMED ce10327a-7bd5-4a88-bb73-af9e7dc921da 61 fields · synced Jul 12, 2026
- EUDAMED fdb79072-af43-4455-88ef-65b4b57f58eb 61 fields · synced Jul 15, 2026
- EUDAMED f2d54251-c495-4162-bb82-09fd58cd87e1 61 fields · synced Aug 4, 2026