Identity
- Trade Name
- Insufflation Tubing,Laparoscopic EUDAMEDDeRoyal FDA UDI
- Generic Name
- Insufflation gas conditioning tubing set FDA UDI
- Device Name
- Insufflation Tubing,Laparoscopic EUDAMEDFDA UDI
- Model / Reference
- 28-0213 EUDAMEDFDA UDI
- Description
- Insufflation Tubing,Laparoscopic FDA UDI
Identifiers
- Catalog Number
- 28-0213 FDA UDI
- Primary DI / UDI-DI
- 00749756329286 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00749756329286 EUDAMED
- FDA Product Code
- NKC FDA UDI
- EMDN Code
- A060102 SURGICAL DRAINAGE CONNECTION MEDICAL TUBES EUDAMED
- GMDN Term
- Insufflation gas conditioning tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.1730 FDA UDI
- Market of Registration
- Netherlands 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
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
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
Insufflation Tubing, Laparoscopic by Deroyal Industries, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00749756329286 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DeRoyal Industries, Inc.
- EUDAMED SRN
- US-MF-000002102
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 58ce6841-66ea-40b1-9261-54cd312af5d1 61 fields · synced Oct 6, 2026
- FDA UDI 574fd67f-0b8b-4937-9688-b76b63a531dc 35 fields · synced May 29, 2026