Identity
- Trade Name
- Femcare FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- Bladeless trocar 8mm/10cm EUDAMED
- Model / Reference
- FN-100-210 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 15055515601619 EUDAMED14714127862498 FDA UDI
- Basic UDI-DI
- B-15055515601619 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France 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
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
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
Category: Laparoscopic access cannula, single-use
Femcare by Unimax Medical Systems Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic access cannula, single-use.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- DR. POYNTER MC — APPLIED MEDICAL RESOURCES CORP. · Class II
- DR.BRIZENDINE LAP CHOLECYSTECTOMY — APPLIED MEDICAL RESOURCES CORP. · Class I
- SECQURE Ultimate — SECQURE SURGICAL, CORP. · Class II
- Secondary trocar with Gas Port + Additional Cannula without Gas Port — PURPLE SURGICAL INTERNATIONAL LIMITED · Class II
- Auto-shield trocar, ribbed cannula — PURPLE SURGICAL INTERNATIONAL LIMITED · Class II
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- CONZALVO ROBOTIC SLEEVE — APPLIED MEDICAL RESOURCES CORP. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unimax Medical Systems Inc.
Sources (2)
- FDA UDI b3d57428-3399-4f41-8109-16ad2fb13d18 32 fields · synced Jul 14, 2026
- EUDAMED af535b74-547d-4e9d-88e0-9167b3e9daf5 61 fields · synced Jul 14, 2026