Identity
- Trade Name
- Pocket Press EUDAMEDFDA UDI
- Generic Name
- Pressure bandage, non-latex, single-use FDA UDI
- Device Name
- Pocket Press EUDAMEDPost-CIED Implant Compression Bandage FDA UDI
- Model / Reference
- PKT21LT EUDAMEDPKT21 FDA UDI
- Description
- Post-CIED Implant Compression Bandage FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10860280002609 EUDAMEDFDA UDI
- Basic UDI-DI
- 08602800026PKT21LT EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M0304010302 ELASTIC COMPRESSION BANDAGES, ADHESIVE, MEDIUM EXTENSIBILITY (70-140%) EUDAMED
- GMDN Term
- Pressure bandage, non-latex, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Market of Registration
- Italy 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Pocket Press by Compress Innovations, LLC — 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 | 08602800026PKT21LT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Compress Innovations, LLC
- EUDAMED SRN
- US-MF-000047962
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED eb4bba04-8479-488e-840e-0bf66023b41f 61 fields · synced Jun 18, 2026
- FDA UDI 9b4d7dcf-a9b5-4373-afe3-7209ec7609b7 34 fields · synced May 30, 2026