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Surgical aspiration with bone filter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HY-12014Model Aspiration System
by Hygitech
Identity
- Trade Name
- Surgical aspiration with bone filter EUDAMEDHYGITECH FDA UDI
- Generic Name
- Airway suction catheter FDA UDI
- Device Name
- Surgical aspiration set compatible with all aspiration systems and composed of: a surgical cannula a filter for collecting bone fragments a 2m PVC tube Supplied with a universal adaptor for aspiration systems. FDA UDI
- Model / Reference
- Aspiration System EUDAMEDHY-12014 EUDAMEDFDA UDI
- Description
- Surgical aspiration set compatible with all aspiration systems and composed of: a surgical cannula a filter for collecting bone fragments a 2m PVC tube Supplied with a universal adaptor for aspiration systems. FDA UDI
Identifiers
- Catalog Number
- HY-12014 FDA UDI
- Primary DI / UDI-DI
- 03615140001991 EUDAMEDFDA UDI
- Basic UDI-DI
- 361514H3ASPI181RG EUDAMED
- FDA Product Code
- EBR FDA UDI
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMED
- GMDN Term
- Airway suction catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Surgical aspiration with bone filter by Hygitech — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 361514H3ASPI181RG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (2)
- EUDAMED a85757b2-3046-4d9d-9f3a-9b0ab0539fa1 61 fields · synced Jun 19, 2026
- FDA UDI 062255a2-00c1-4e69-8832-f8e1a5a482e5 34 fields · synced May 29, 2026