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Surgical aspiration tube
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY-12025Model Aspiration Tube
by Hygitech
Identity
- Trade Name
- Surgical aspiration tube EUDAMEDHYGITECH FDA UDI
- Generic Name
- Airway suction catheter FDA UDI
- Device Name
- Sterile transparent PVC suction tube with 2 connectors at the extremities. Length: 2.70m FDA UDI
- Model / Reference
- Aspiration Tube EUDAMEDHY-12025 EUDAMEDFDA UDI
- Description
- Sterile transparent PVC suction tube with 2 connectors at the extremities. Length: 2.70m FDA UDI
Identifiers
- Catalog Number
- HY-12025 FDA UDI
- Primary DI / UDI-DI
- 03615140001908 EUDAMEDFDA UDI
- Basic UDI-DI
- 361514H3ASPI183RL EUDAMED
- FDA Product Code
- EFS FDA UDI
- EMDN Code
- A060102 SURGICAL DRAINAGE CONNECTION MEDICAL TUBES EUDAMED
- GMDN Term
- Airway suction catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6510 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
Category: Suction/irrigation tubing, single-use
Surgical aspiration tube by Hygitech — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suction/irrigation tubing, single-use.
- Non-sterile aspiration tubes — Produtos Médicos Hospitalares, SA · Class I
- AMSure® Suction Connecting Tube with Pre-Attached Yankauer — AMSINO INTERNATIONAL, INC. · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Conneting tube — Grena (Qingdao) Medical Devices Ltd. · Class I
- Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
- Bioseal Inc. — BIOSEAL · Class I
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 | 361514H3ASPI183RL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (2)
- EUDAMED 77274612-9b29-4666-8b92-17015a2da334 61 fields · synced Jun 19, 2026
- FDA UDI 61e03583-ad32-43d9-86da-c07fde346800 34 fields · synced May 30, 2026