Identity
- Trade Name
- Synergy Pro EUDAMED
- Device Name
- PICC Procedure Pack EUDAMED
- Model / Reference
- DM0102289/AMD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00876604005938 EUDAMED
- Basic UDI-DI
- 087660400PP-PICC01001N8 EUDAMED
- EMDN Code
- C010102 PERIPHERAL I.V. CATHETER SYSTEMS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The intended purpose of the PICC Procedure Pack is to provide convenience accessories to assist vascular professionals and physicians in attaining the surgical insertion of peripherally central venous catheters. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Synergy Pro by Health Line International Corp — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: SYNERGY CT PICC™ Line Max Barrier Kit
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 087660400PP-PICC01001N8 | Class III | Active |
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Manufacturer
- Manufacturer
- Health Line International Corp
- EUDAMED SRN
- US-PR-000013766
Sources (1)
- EUDAMED f9bbbd0a-ec5b-4cb9-b38f-4ac8026685aa 61 fields · synced Jun 19, 2026