Identity
- Trade Name
- Panda Adhesive Eye Protectors FDA UDI
- Generic Name
- Eye pad FDA UDI
- Device Name
- Adhesive Eye Protectors EUDAMEDPediatric Adhesive Eye Protectors FDA UDI
- Model / Reference
- 70-04PED EUDAMEDFDA UDI
- Description
- Pediatric Adhesive Eye Protectors FDA UDI
Identifiers
- Catalog Number
- 70-04PED FDA UDI
- Primary DI / UDI-DI
- 00690521025165 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210AEPNS1000VU EUDAMED
- FDA Product Code
- HMP FDA UDI
- EMDN Code
- H900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
- GMDN Term
- Eye pad FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4440 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Adhesive Eye Protectors by Batrik Medical Manufacturing 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 | 6905210AEPNS1000VU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 8f584ae1-fd2d-4963-930c-b0a65861dc33 61 fields · synced Jun 19, 2026
- FDA UDI a4db9adf-a026-4fd5-979f-6ef55d3ec6cf 36 fields · synced May 30, 2026