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Astoflo® Plus Eco
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AFP300DKRef WP33Ref AFP300EU
Identity
- Trade Name
- ASTOFLO PLUS ECO EUDAMEDASTOFLO® PLUS ECO FDA UDI
- Generic Name
- Conduction blood/fluid warmer FDA UDI
- Device Name
- ASTOFLO PLUS ECO - Control unit EUDAMEDASTOFLO PLUS ECO - Heating profile EUDAMEDBlood and infusion warmer FDA UDIHeating profile FDA UDI
- Model / Reference
- AFP300EU EUDAMEDFDA UDIWP33 EUDAMEDFDA UDIAFP300DK EUDAMEDAFP300UK FDA UDI
- Description
- Blood and infusion warmer FDA UDIHeating profile FDA UDI
Identifiers
- Catalog Number
- AFP300UK FDA UDIAFP300EU FDA UDIWP33 FDA UDI
- Primary DI / UDI-DI
- 04260114140658 EUDAMEDFDA UDI04260114140696 EUDAMEDFDA UDI04260114141174 EUDAMED04260114140597 FDA UDI
- Basic UDI-DI
- B-04260114141174 EUDAMEDB-04260114140696 EUDAMEDB-04260114140658 EUDAMED
- 510(k) Number
- K082765 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- EMDN Code
- A030105 FLUIDS HEATING SYSTEMS EUDAMED
- GMDN Term
- Conduction blood/fluid warmer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Market of Registration
- Denmark EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Conduction blood/fluid warmer
Astoflo® Plus Eco by Stihler Electronic GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Conduction blood/fluid warmer.
- Ranger™ — 3M COMPANY · Class II
- ThermaCor 1200 Infusion System — Smisson-Cartledge Biomedical, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- EXPRESS FLUID WARMER — NxStage Medical, Inc. · Class II
- °M Warmer System - Charger — Mequ A/S · Class II
- QINFLOW AC STATION INTRO SET WARRIOR — QUALITY IN FLOW LTD · Class II
- QINFLOW AC STATION EXTENDED SET EXTREME — QUALITY IN FLOW LTD
- therMaxTherMax Blood Warmer — Baxter Healthcare Corp · Class II
Cleared under the same submission
K082765 also covers:
- ASTOFLO® PLUS ECO — Stihler Electronic GmbH
- ASTOFLO® PLUS ECO — Stihler Electronic GmbH
- ASTOFLO® PLUS ECO — Stihler Electronic GmbH
- ASTOFLO® PLUS ECO — Stihler Electronic GmbH
- ASTOFLO® PLUS ECO — Stihler Electronic GmbH
- ASTOFLO® PLUS ECO — Stihler Electronic GmbH
- ASTOFLO® PLUS ECO — Stihler Electronic GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Stihler Electronic GmbH
Sources (6)
- FDA UDI 99b6cef1-d684-4b25-a406-ed65c96d9126 35 fields · synced Jul 18, 2026
- FDA UDI 31118659-666b-482a-ae3f-1f470132950d 35 fields · synced May 30, 2026
- FDA UDI f4e30e90-68ae-4915-80f0-3d8c21f40133 35 fields · synced May 30, 2026
- EUDAMED 1575a060-7fc2-4669-b4cc-0ecf983e0740 61 fields · synced Jul 8, 2026
- EUDAMED bb9391ee-86cd-481b-99ba-44991f3924fb 61 fields · synced Jul 15, 2026
- EUDAMED 116b75bf-3dd5-4e98-b2ca-471ea127b144 61 fields · synced Jul 18, 2026