← Back to catalogue
Spiroguard Integral Mouthpiece with Nose Clip
EUDAMEDClass IIa (EU MDR)
Ref 2800/31BFKBAUA001/0001
Identity
- Trade Name
- Spiroguard Integral Mouthpiece with Nose Clip EUDAMED
- Device Name
- Respiratory Filters - Various EUDAMED
- Model / Reference
- 2800/31BFKBAUA001/0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060120959386 EUDAMED
- Basic UDI-DI
- 506012095Cat277 EUDAMED
- EMDN Code
- R020302 RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Category: Straight/elbow breathing circuit connector, reusable
Spiroguard Integral Mouthpiece with Nose Clip by GVS Filter Technology UK Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Straight/elbow breathing circuit connector, reusable.
- 7000 CONNECTORS — HANS RUDOLPH, INC. · Class I
- Airway Connector — VADI Medical Technology Co., Ltd. · Class IIa
- AincA® — Anesthesia Associates, Inc. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- Portex — ICU MEDICAL, INC. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- Connector, 6M, 4M, K Resin — GaleMed (Xiamen) Co., Ltd. · Class IIa
- Connector, 32M, 22M, PP — GaleMed (Xiamen) Co., Ltd. · Class IIa
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 | 506012095Cat277 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GVS Filter Technology UK Limited
- EUDAMED SRN
- UK-MF-000045036
- Authorised Representative
- GVS S.p.A. IT-AR-000028148
Sources (1)
- EUDAMED 39143c94-03f4-4065-94c9-cbb619707f2c 61 fields · synced Oct 7, 2026