Identity
- Trade Name
- Zip Stitch Dressing EUDAMEDTape and bandage, adhesive, adjustable closing mechanism, OTC use FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- Zip Stitch Dressing EUDAMEDUsed to provide binding force on wound dressings or limbs for binding and fixation purposes. FDA UDI
- Model / Reference
- TB-3 EUDAMEDFDA UDI
- Description
- Used to provide binding force on wound dressings or limbs for binding and fixation purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971257033704 EUDAMEDFDA UDI
- Basic UDI-DI
- 697125703TXBD01NC EUDAMED
- FDA Product Code
- PYO FDA UDI
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
- GMDN Term
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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: Scar-management dressing, reusable
Zip Stitch Dressing by Weihai Kangzheng Medical Equipments Technology Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Scar-management dressing, reusable.
- MEDLOT — Henan Maidingkang Medical Technology Co., Ltd. · Class I
- Blister plaster — Shenzhen Huashengyuan Technology Co., Ltd · Class I
- Transeal Triple Release — DEROYAL INDUSTRIES, INC. · Class I
- URGO Ongles abimés, par mycoses et traumatismes légers — Laboratoires URGO HEALTHCARE · Class I
- Wound Plaster — Jinhua Jingdi Medical Supplies Co.,Ltd. · Class I
- Oleeva Fabric 2x8 — BIO MED SCIENCES, INC. · Class I
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc. · Class I
- THERAFOAM — BIODERMIS LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697125703TXBD01NC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000039037
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 75b2bd2b-3aaa-4f89-9a3f-92ab02cf2a76 61 fields · synced Jul 24, 2026
- FDA UDI 2e57ba6c-023f-42cf-8362-17eed38c1a90 33 fields · synced May 30, 2026