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Gri-Fill Peristaltic Set
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 735017Model Eur.Sur510(k) K162216
Identity
- Trade Name
- GRI-FILL PERISTALTIC SET EUDAMED
- Device Name
- GRI-FILL PERISTALTIC SET EUDAMED
- Model / Reference
- Eur.Sur EUDAMED735017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437017294009 EUDAMED
- Basic UDI-DI
- 8437017294A070003NB EUDAMED
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
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
Gri-Fill Peristaltic Set by Laboratorios Grifols, S.a. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162216 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8437017294A070003NB | Class I | Active |
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Manufacturer
- Manufacturer
- Laboratorios Grifols S.A.
- EUDAMED SRN
- ES-MF-000000767
- FDA Applicant
- Laboratorios Grifols, S.A.
Sources (2)
- EUDAMED a9a84396-7db1-421b-ad5f-bc73bac5d43d 85 fields · synced Jun 18, 2026
- FDA 510(k) K162216 1 fields · synced May 18, 2026