Identity
- Trade Name
- Prosthetic Adhesives FDA UDI
- Generic Name
- Skin surface device adhesive FDA UDI
- Device Name
- Prosthetic Adhesives EUDAMEDSolvent Based Silicone Pressure Sensitive (PSA) Adhesives to adhere craniofacial prostheses to skin. FDA UDIWater Based Pressure Sensitive (PSA) Adhesives to adhere prostheses to skin. FDA UDI
- Model / Reference
- G609 EUDAMEDG609-T EUDAMEDProBond Secure Adhesive, 30ml FDA UDIProBond Adhesive 37ml FDA UDI
- Description
- Solvent Based Silicone Pressure Sensitive (PSA) Adhesives to adhere craniofacial prostheses to skin. FDA UDIWater Based Pressure Sensitive (PSA) Adhesives to adhere prostheses to skin. FDA UDI
Identifiers
- Catalog Number
- G626 FDA UDIG609 FDA UDI
- Primary DI / UDI-DI
- 05060483010076 EUDAMEDFDA UDI05060483016160 EUDAMED05060483015736 FDA UDI
- Basic UDI-DI
- 506048301TF4DB EUDAMED
- Direct Marketing DI
- 05060483010076 EUDAMED05060483016160 EUDAMED
- FDA Product Code
- GBJ FDA UDI
- EMDN Code
- A108008 ADHESIVES FOR ABDOMINAL OSTOMY DEVICES EUDAMED
- GMDN Term
- Skin surface device adhesive FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3750 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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: Skin surface device adhesive
Prosthetic Adhesives by Technovent Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Skin surface device adhesive.
- Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50 — UROCARE PRODUCTS, INC. · Class I
- Strados Labs — Strados Labs · Class II
- Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.) — UROCARE PRODUCTS, INC. · Class I
- Protecta-Gel® — J.R.J. MEDICAL INNOVATIONS, LLC · Class I
- POPS — TRIFECTA THERAPEUTICS LLC · Class I
- HYGITECH — HYGITECH · Class I
- ViveCare — VIVE HEALTH LLC · Class I
- ViveCare — VIVE HEALTH LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Technovent Limited
Sources (4)
- FDA UDI 4722726c-5da3-4cd6-81c6-dc713406b88c 35 fields · synced Jul 20, 2026
- FDA UDI 875ab406-2dd8-4f65-9c06-7f256272c695 35 fields · synced May 30, 2026
- EUDAMED a2d26fbd-7cc4-4aac-964f-25c27f53c693 61 fields · synced Jul 9, 2026
- EUDAMED 8f264611-9129-4998-b26f-c02cfcf808a0 61 fields · synced Jul 20, 2026