← Back to catalogue
Fukushima Tear Drop Suction Tube Straight Malleable 4 Fr. 16.5 cm - 6 1/2" Ø 1.…
EUDAMEDClass IIa (EU MDR)
Ref TR-113-04
Identity
- Trade Name
- Fukushima Tear Drop Suction Tube Straight Malleable 4 Fr. 16.5 cm - 6 1/2" Ø 1.3 mm EUDAMED
- Device Name
- SUCTION TUBES & CANNULAS EUDAMED
- Model / Reference
- TR-113-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056111316306 EUDAMED
- Basic UDI-DI
- 50554459SUCTANDCANNB4 EUDAMED
- EMDN Code
- L030101 SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Surgical/emergency suction cannula, non-illuminating, reusable
Fukushima Tear Drop Suction Tube Straight Malleable 4 Fr. 16.5 cm - 6 1/2" Ø 1.… by Surtex Instruments Ltd — Class IIa — MDR — listed in EUDAMED
Similar devices
Also classified as Surgical/emergency suction cannula, non-illuminating, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- MicroFrance® — Integra Microfrance · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SCANLAN® Variable Suction Rotatable Tips — SCANLAN INTERNATIONAL INC · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class II
- LAZIC — Peter Lazic GmbH · Class II
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 | 50554459SUCTANDCANNB4 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surtex Instruments Ltd
- EUDAMED SRN
- GB-MF-000023183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3d0d91db-0975-4645-88cd-2b70e20ce113 61 fields · synced Oct 6, 2026