← Back to catalogue
MyoSure REACH Tissue Removal Device
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10-401FC
Identity
- Trade Name
- MyoSure REACH Tissue Removal Device EUDAMEDFDA UDI
- Generic Name
- Tissue morcellation system FDA UDI
- Device Name
- MyoSure REACH Tissue Removal Device; MyoSure LITE Tissue Removal Device; MyoSure XL Tissue Removal Device; MyoSure XL Tissue Removal Device for Fluent EUDAMEDThe MyoSure Tissue Removal System is intended for hysteroscopic intrauterine resection procedures by a trained gynecologist to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception. FDA UDI
- Model / Reference
- 10-401FC EUDAMEDFDA UDI
- Description
- The MyoSure Tissue Removal System is intended for hysteroscopic intrauterine resection procedures by a trained gynecologist to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception. FDA UDI
Identifiers
- Catalog Number
- 10-401FC FDA UDI
- Primary DI / UDI-DI
- 15420045504530 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455GSSMYOSURETRDQK EUDAMED
- Direct Marketing DI
- 15420045504530 EUDAMED
- 510(k) Number
- K152723 FDA UDI
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- Z12080204 MORCELLATORS EUDAMED
- GMDN Term
- Tissue morcellation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Market of Registration
- Belgium 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
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
Yes
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
No
FDA UDI
MyoSure REACH Tissue Removal Device by Hologic Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 54200455GSSMYOSURETRDQK | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000003310
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (2)
- EUDAMED ff0bab6d-a02f-452b-b08c-7d9e1fd59819 61 fields · synced Jun 20, 2026
- FDA UDI 48a75ec9-2ef1-4bf2-8a5a-3807e46502dc 35 fields · synced May 29, 2026