Identity
- Trade Name
- Tapes, Adhesive EUDAMEDOrantech FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- Tapes, Adhesive EUDAMEDUsed with Masimo original multi-site sensors FDA UDI
- Model / Reference
- DPT-P-M EUDAMEDFDA UDI
- Description
- Used with Masimo original multi-site sensors FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691966357 EUDAMEDFDA UDI
- Basic UDI-DI
- 69416919ORANTECH15R2 EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M0304010302 ELASTIC COMPRESSION BANDAGES, ADHESIVE, MEDIUM EXTENSIBILITY (70-140%) 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
- Denmark 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Tapes, Adhesive by Orantech Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 69416919ORANTECH15R2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (2)
- EUDAMED 0179fa74-3df9-4c8f-96a7-ed3e7e3d53f3 61 fields · synced Jul 11, 2026
- FDA UDI 085a64b1-0f87-498d-97e0-c3c0b75b7b66 33 fields · synced May 30, 2026