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General product information only, not medical advice. For decisions about a specific patient or wound, follow a clinician and the manufacturer’s instructions for use.
Short answer
Hypafix is a brand of medical adhesive tape sold in white, transparent and skin-sensitive versions, used to hold a dressing in place on the skin. In the FDA’s Global Unique Device Identification Database (GUDID) it is listed under product code KGX, “Tape and bandage, adhesive”, as a Class I device exempt from premarket notification.
Definition and scope
The thirteen Hypafix records in GUDID (checked 2026-10-30 through the openFDA UDI API) all carry the brand name Hypafix, name BSN medical GmbH as labeler, show the status “In Commercial Distribution”, are marked as not sterile, and fall under 21 CFR 880.5240. The same records use the GMDN term “Dressing-fixation skin adhesive tape, non-silicone”, defined as a long, narrow flexible band coated with a pressure-sensitive adhesive, intended to adhere non-invasively to the skin to fix a dressing in place or to attach objects to the skin.
That makes Hypafix a fixation product, not a dressing. A wound dressing is the layer that covers or contacts the wound; fixation tape is what keeps that layer where it is. Older FDA clearances reflect the same idea: the 510(k) records for the Hypafix name are titled “Dressing Retention Sheet” and “Post Operative Dressing”.
How it is used in practice
Federal regulation describes the device class in general terms. 21 CFR 880.5240(a) defines a medical adhesive tape as a device “intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive”, used among other things to cover and protect wounds and “to secure objects to the skin”. The GMDN term above narrows this to holding a dressing in place. Application technique, skin preparation and wear time are set by the manufacturer’s instructions for use and the treating clinician, and are not covered here.
Types: the Hypafix lines and sizes in GUDID
GUDID lists three product lines. The table gives width by length for each record, as listed in GUDID (checked 2026-10-30). “PHARM” appears in the description text of two white-tape records.
| Line | Width x length | Model number |
|---|---|---|
| White | 5 cm x 10 m | 71443-01 |
| White | 10 cm x 10 m | 71443-02 |
| White | 15 cm x 10 m | 71443-03 |
| White | 5 cm x 2 m | 71939-21 |
| White (PHARM) | 10 cm x 2 m | 71939-19 |
| White (PHARM) | 15 cm x 2 m | 71939-20 |
| Transparent | 5 cm x 10 m | 72378-00 |
| Transparent | 10 cm x 10 m | 72378-01 |
| Transparent | 15 cm x 10 m | 72378-02 |
| Transparent | 10 cm x 2 m | 72378-03 |
| Skin Sensitive | 5 cm x 5 m | 79966-01 |
| Skin Sensitive | 10 cm x 5 m | 79966-02 |
| Skin Sensitive | 10 cm x 2 m | 79966-04 |
Hypafix sizes at a glance
Widths run 5, 10 and 15 cm. Lengths are 2 m, 5 m or 10 m depending on the line: the 5 m rolls appear only in the Skin Sensitive line, and a 15 cm width is not listed for Skin Sensitive. Each GUDID record describes a single roll; the table is a catalogue of what the database lists, not a statement of what is stocked anywhere.
Where it matters for labs, clinics and supply decisions
- Regulatory class. Under 21 CFR 880.5240(b) this device type is Class I (general controls) and exempt from the premarket notification procedures, subject to the limitations in 21 CFR 880.9.
- Identification. Each size has its own model number and device record in AccessGUDID, which is the direct way to confirm the exact product named on a supply list.
- Brand history. openFDA lists three 510(k) records under the Hypafix name from Smith and Nephew entities: K833916 (decision 1984-03-12, product code KGX), K850282 (1985-05-07, NAD) and K894254 (1989-08-31, NAD). Current GUDID records name BSN medical GmbH as labeler.
For adjacent supplies, see the CASRAI guides on medical tape, gauze and bandages, and the comparison of hypoallergenic and standard medical tape.
Common misunderstandings
- “It is a dressing.” It is classed as adhesive tape used to fix a dressing; it is not itself the wound-contact layer.
- “It is sterile.” The GUDID records show it as not sterile.
- “All Hypafix is the same.” GUDID separates white, transparent and skin-sensitive lines, each with its own sizes.
FAQ
What is Hypafix?
A brand of adhesive tape for fixing dressings to the skin, classed by the FDA as “Tape and bandage, adhesive” (product code KGX), Class I.
What sizes does Hypafix come in?
GUDID lists 13 records: widths of 5, 10 and 15 cm and lengths of 2, 5 and 10 m across the white, transparent and skin-sensitive lines; the table above gives each combination.
Does Hypafix need an FDA 510(k)?
Class I adhesive tape under 21 CFR 880.5240 is exempt from premarket notification, subject to 21 CFR 880.9. Older Hypafix-named 510(k) records from 1984 to 1989 appear in openFDA.
Who makes Hypafix?
The current GUDID records list BSN medical GmbH as labeler; the 1980s 510(k) records list Smith and Nephew entities.
Sources
- FDA / NLM AccessGUDID data via the openFDA UDI API, brand_name Hypafix, 13 records, checked 2026-10-30: api.fda.gov/device/udi.json; database home accessgudid.nlm.nih.gov.
- openFDA 510(k) records K833916, K850282 and K894254, checked 2026-10-30: api.fda.gov/device/510k.json.
- openFDA device classification, product code KGX, checked 2026-10-30: api.fda.gov/device/classification.json.
- 21 CFR 880.5240, Medical adhesive tape and adhesive bandage, checked 2026-10-30: law.cornell.edu.
