Profimed
by Θ.καζαντζιδης Αε - Medipac 124 variants
Part of a family of 124 devices: see the family page
Ref PR100T-4
Profimed (PR100T-4) is a Class III device made by Θ.καζαντζιδης Αε - Medipac, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 5206913PROFIMED8Q) with CE/MDR certificate C07 GR027637 2412 valid until 19 Dec 2029, active as of 26 Oct 2026.
Active
CE MDR
Valid until
19 Dec 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5206913PROFIMED8Q 05206913014263 | Date20 May 2026 | StatusActive |
Official records
- EUDAMED public site 5206913PROFIMED8Q
Certificates
- C07 GR027637 2412 Active
Technical documentation EU MDR
- Certifier
- HTCert (Health Technology Certification Ltd) 2803
- Issued
- 16 Mar 2026
- Expires
- 19 Dec 2029
Timeline
- Certificate issued EUDAMED C07 GR027637 2412
- Registered EUDAMED 5206913PROFIMED8Q
- Certificate expires EUDAMED C07 GR027637 2412
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- PR100T-4
- Primary DI / UDI-DI
- 05206913014263
- Basic UDI-DI
- 5206913PROFIMED8Q
- EMDN code
- H010201010501 Polytetrafluoroethylene (ptfe) monofilament with needle
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- GR-MF-000027637
Similar devices in this category
Other devices filed under POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE.
- Demetech PTFE TE256013F4P by DemeTECH Corp
- GORE-TEX Suture 4N08 by W. L. Gore & Associates, Inc.
- GORE-TEX Suture 6N16 by W. L. Gore & Associates, Inc.
- OSSEOGUARD® OS4013PR by ZimVie US Corp LLC
- Cytoplast™ PTFE Suture CS0618RC by OSTEOGENICS BIOMEDICAL, INC.
- Cytoplast™ PTFE Suture CS0528BK by OSTEOGENICS BIOMEDICAL, INC.
- Biotex BT3016 by PURGO BIOLOGICS Inc.
- OSSEOGUARD® OS4016 by ZimVie US Corp LLC
- Demetech PTFE TE254017B6P by DemeTECH Corp
- Biotex BT501655 by PURGO BIOLOGICS Inc.