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Hemorrhoidal Multi-Band Ligator with Anoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HM601-4BModel HM/601-4-BRef HM601-4-B
Identity
- Trade Name
- Hemorrhoidal Multi-Band Ligator with Anoscope EUDAMEDHemorrhoidal Multi-Band Ligator with Anoscope FDA UDI
- Generic Name
- Haemorrhoid ligation set FDA UDI
- Device Name
- Bougie Dilator Sets EUDAMEDHemorrhoidal Multi-Band Ligator with Anoscope EUDAMEDThis product is used to treat the hemorrhoids in assistance of anoscope for adults only. FDA UDI
- Model / Reference
- HM/601-4-B EUDAMEDHM601-4B EUDAMEDHM601-4-B EUDAMEDHM/601-3-A FDA UDI
- Description
- This product is used to treat the hemorrhoids in assistance of anoscope for adults only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06951862291584 EUDAMED06951862291539 FDA UDI
- Basic UDI-DI
- B-06951862291584 EUDAMED
- FDA Product Code
- FHN FDA UDI
- EMDN Code
- G020401 HAEMORRHOID LIGATURE SETS EUDAMED
- GMDN Term
- Haemorrhoid ligation set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hemorrhoidal Multi-Band Ligator with Anoscope by Changzhou Health Microport Medical Device Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06951862291584 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Changzhou Health Microport Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000033536
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (3)
- EUDAMED 2e03980d-286e-4b43-8586-1e36363547ea 61 fields · synced Oct 7, 2026
- FDA UDI 5e88b02e-9997-46cd-9372-0d55bb1aa363 33 fields · synced May 30, 2026
- EUDAMED 9ba4029a-27dc-4a31-bd6c-d036cf4580a4 61 fields · synced Jun 20, 2026