Identity
- Trade Name
- ERPeak FDA UDI
- Generic Name
- General specimen container IVD, additive/medium FDA UDI
- Device Name
- Endometrial Biopsy Kit EUDAMEDIVD Sample kit FDA UDI
- Model / Reference
- ER20190829-03 EUDAMEDFDA UDI
- Description
- IVD Sample kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937027718 EUDAMED60888937027183 FDA UDI
- Basic UDI-DI
- 0888937TD125ZQ EUDAMED
- FDA Product Code
- NNK FDA UDI
- EMDN Code
- W05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED
- GMDN Term
- General specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: General specimen container IVD, additive/medium
ERPeak by CooperSurgical, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 030436e7-537c-4fc1-b340-9720b49c8704 33 fields · synced Jul 9, 2026
- EUDAMED 76a48fbc-5d67-488c-b5f2-6a7fee687b4f 61 fields · synced Jul 9, 2026