Identity
- Trade Name
- Mediflex FDA UDI
- Generic Name
- Externally-anchored laparoscopic retraction thread FDA UDI
- Device Name
- Port Free Retractors EUDAMEDPort Free Retractor T-PEA Lifter with Long Needle FDA UDI
- Model / Reference
- TPL5X180 EUDAMEDFDA UDI
- Description
- Port Free Retractor T-PEA Lifter with Long Needle FDA UDI
Identifiers
- Catalog Number
- TPL5X180 FDA UDI
- Primary DI / UDI-DI
- 08904332600490 EUDAMEDFDA UDI
- Basic UDI-DI
- 089043326PFR0146M EUDAMED
- FDA Product Code
- GAD FDA UDINWV FDA UDI
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
- GMDN Term
- Externally-anchored laparoscopic retraction thread FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI884.1720 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Externally-anchored laparoscopic retraction thread
Mediflex by Endosys Healthcare India Private Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Externally-anchored laparoscopic retraction thread.
- T'Lift® — PETERS SURGICAL · Class I
- Mediflex — ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Endosys Healthcare India Private Limited
Sources (2)
- FDA UDI 5d064b4b-2cee-4670-a78e-ecd3d0d37369 35 fields · synced Jun 20, 2026
- EUDAMED 7bd46e70-d1ac-41e6-ac5e-ec2348aade6b 61 fields · synced Jun 20, 2026