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Sign in to claim this brandGBUK ENTERAL LIMITED
US
Last updated May 23, 2026
What GBUK ENTERAL LIMITED makes
GBUK Enteral Limited manufactures enteral feeding and drainage products, including nasogastric feeding tubes, single-use oral/enteral syringes with ENFit connectors, and gastric drainage bags. Their portfolio also covers protective caps and vial adaptors for enteral nutrition, as well as pH strips for gastric monitoring and stoma buttons for intestinal or urinary applications. Extension sets for enteral tubes are also part of their product range.
These devices are regulated under FDA pathways, with most classified as Class I or Class II, and are listed under the 510(k) and UDI programs. The company operates from the United States, adhering to applicable medical device regulations for enteral and drainage products.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does GBUK Enteral Limited manufacture?
GBUK Enteral Limited specializes in enteral feeding and drainage devices. Their product range includes nasogastric feeding tubes, single-use oral/enteral syringes with ENFit connectors, gastric drainage/decompression bags, and protective caps for enteral tubes. They also produce vial/bottle adaptors, gastric pH strips for monitoring, and stoma buttons for intestinal or urinary applications. These devices are designed to support enteral nutrition and gastrointestinal decompression.
Where is GBUK Enteral Limited based, and what regulations do their devices follow?
GBUK Enteral Limited is based in the United States. Their devices are regulated under FDA pathways, including the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. Since most of their products fall under Class I or Class II classifications, they must comply with FDA requirements for enteral and drainage devices, ensuring safety, performance, and proper labeling.
Which regulatory registries or databases list GBUK Enteral Limited’s devices?
GBUK Enteral Limited’s devices are listed under the FDA’s 510(k) premarket clearance program and the UDI system. These registries ensure traceability and compliance tracking for medical devices in the U.S. The 510(k) process verifies that a device is at least as safe and effective as a legally marketed predicate device, while the UDI system provides a unique identifier for each device to improve tracking and reduce medical errors.
How are GBUK Enteral Limited’s devices classified under FDA regulations?
GBUK Enteral Limited’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, such as enteral feeding or gastric drainage.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 216643186
Catalogue (191)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Enteral | EISO-35 | FDA UDI | Class II | Active |
| Enteral | NC06.080ISOSAF-ROW | FDA UDI | Class II | Active |
| Enteral | ELDISO-3BNS-US | FDA UDI | Class II | Active |
| CareTip | OBA-A | FDA UDI | Class I | Active |
| Enteral | EISO-1 | FDA UDI | Class II | Unknown |
| Enteral | ELDISO-1BNS-US | FDA UDI | Class II | Active |
| Enteral | EISO-12BNS-US | FDA UDI | Class II | Unknown |
| Enteral | EISO-20 | FDA UDI | Class II | Unknown |
| CareTip | ABOSPFCO-1-500NS | FDA UDI | Class I | Active |
| Enteral | ESCF.075-ISOSAF | FDA UDI | Class II | Active |
| Enteral | PFCO-50NS | FDA UDI | Class I | Active |
| Nutricare | YNC08.080ISOSAF-ROW | FDA UDI | Class II | Active |
| Enteral | NC06.050ISOSAF-ROW | FDA UDI | Class II | Active |
| CareTip | ABOS-1-NS | FDA UDI | Class I | Active |
| Enteral | ELDISO-PFC-1 | FDA UDI | Class II | Active |
| Enteral | FNISO-50 | FDA UDI | Class I | Active |
| Enteral | NCF08.90 | FDA UDI | Class II | Active |
| Nutricare | YNC08.092ISOSAF-ROW | FDA UDI | Class II | Active |
| Nutricare | YNC06.110ISOSAF-ROW | FDA UDI | Class II | Active |
| CareTip | OBA-D | FDA UDI | Class I | Active |
| Enteral | EISO-10 | FDA UDI | Class II | Unknown |
| CareTip | OBA-B | FDA UDI | Class I | Active |
| Nutricare | YNC06.050ISOSAF-ROW | FDA UDI | Class II | Active |
| CareTip | ABOS-5-NS | FDA UDI | Class I | Active |
| Enteral | VED-691 | FDA UDI | Class I | Active |
| Enteral | NC08.092ISOSAF-ROW | FDA UDI | Class II | Active |
| Enteral | NCF04.50 | FDA UDI | Class II | Active |
| CareTip | OS-5 | FDA UDI | Class I | Active |
| CareTip | ABOS-20-NS | FDA UDI | Class I | Active |
| CareTip | ABOS-3-NS | FDA UDI | Class I | Active |
| Enteral | SELDISO-PFC-1 | FDA UDI | Class II | Active |
| Enteral | NCC-05-75 | FDA UDI | Class II | Active |
| Kentec | AMP-PIBA-3.5 | FDA UDI | Class I | Active |
| Enteral | NC12.092ISOSAF-ROW | FDA UDI | Class II | Active |
| Enteral | PHX2-9 | FDA UDI | Class I | Active |
| Enteral | NCF05.50 | FDA UDI | Class II | Active |
| Enteral | NCF08.40 | FDA UDI | Class II | Active |
| Nutricare | NCF10.110 | FDA UDI | Class II | Active |
| Enteral | BESCF.075-ISOSAF-US | FDA UDI | Class II | Active |
| CareTip | ABOSPFCO-5-500NS | FDA UDI | Class I | Active |
| Nutricare-Isosaf Naso-Gastric Feeding Tube | K151503 | FDA 510(k) | Class II | Active |
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