Identity
- Trade Name
- PragmaVAC® EUDAMED
- Device Name
- PragmaVAC® EUDAMED
- Model / Reference
- PVAC-TQ-G3 EUDAMEDPI-TCF-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06286939330256 EUDAMED06286939330010 EUDAMED
- Basic UDI-DI
- 628693933PragmaVAC-M2.0ZE EUDAMED
- EMDN Code
- A06010199 VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
PragmaVAC® by Pragmatic Innovation Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 628693933PragmaVAC-M2.0ZE | Class I | Active |
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Manufacturer
- Manufacturer
- Pragmatic Innovation Inc.
- EUDAMED SRN
- CA-MF-000036518
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (2)
- EUDAMED ddbac602-d42a-4b3a-87a4-61c102cc41e8 61 fields · synced Jul 31, 2026
- EUDAMED 4d72939e-cb3d-4727-bbc3-33d0f2124147 61 fields · synced May 18, 2026